GSPR Checklist

Index
1. Checklist 3
2. Reference documents or additional information 80

Document title
Instruction for use for the author of this document: blue text is background information and is intended to assist during
preparation of this document. This background information must be deleted or replaced before the document is
released. The final version may only contain product specific contents. Wherever possible, references should be used.
(Redundant information shall be avoided).

Device:
Basic UDI-DI: Basic UDI-DI
Manufacturer:
Manufacturer SRN: Manufacturer SRN

Table 1 Signatures
Name and function Signature Date
Author
Review
Release

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Table 2 Document history

Version Date Name and function Change

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1. Checklist

Table 3 GSPR Checklist

# Requirements Requirements Applicable Applied standards, Detailed indication of Complied with
yes / no Common Specifications, supporting documents and yes / no
other speciation methods used.
documents
1 I. General requirements
2 SPR 1: Devices shall achieve the performance
Performance and intended by their manufacturer and shall
safety be designed and manufactured in such a
way that, during normal conditions of use,
they are suitable for their intended
purpose. They shall be safe and effective
and shall not compromise the clinical
condition or the safety of patients, or the
safety and health of users or, where
applicable, other persons, provided that
any risks which may be associated with
their use constitute acceptable risks when
weighed against the benefits to the
patient and are compatible with a high
level of protection of health and safety,
taking into account the generally
acknowledged state of the art.
3 SPR 2: Reduction The requirement in this Annex to reduce
of risks risks as far as possible means the

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reduction of risks as far as possible
without adversely affecting the benefit-
risk ratio.
4 SPR 3: Risk Manufacturers shall establish, implement,
management document and maintain a risk
system management system.
5 Risk management shall be understood as a
continuous iterative process throughout
the entire lifecycle of a device, requiring
regular systematic updating. In carrying
out risk management manufacturers shall:
6 (a) establish and document a risk
management plan for each device;
7 (b) identify and analyse the known and
foreseeable hazards associated with each
device;
8 (c) estimate and evaluate the risks
associated with, and occurring during, the
intended use and during reasonably
foreseeable misuse;
9 (d) eliminate or control the risks referred
to in point (c) in accordance with the
requirements of Section 4;
10 (e) evaluate the impact of information

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from the production phase and, in
particular, from the post-market
surveillance system, on hazards and the
frequency of occurrence thereof, on
estimates of their associated risks, as well
as on the overall risk, benefit-risk ratio and
risk acceptability; and
11 (f) based on the evaluation of the impact
of the information referred to in point (e),
if necessary amend control measures in
line with the requirements of Section 4.
12 SPR 4: Risk Risk control measures adopted by
control measures manufacturers for the design and
and residual risks manufacture of the devices shall conform
to safety principles, taking account of the
generally acknowledged state of the art.
To reduce risks, Manufacturers shall
manage risks so that the residual risk
associated with each hazard as well as the
overall residual risk is judged acceptable.
In selecting the most appropriate
solutions, manufacturers shall, in the
following order of priority:
13 (a) eliminate or reduce risks as far as
possible through safe design and

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manufacture;
14 (b) where appropriate, take adequate
protection measures, including alarms if
necessary, in relation to risks that cannot
be eliminated; and
15 (c) provide information for safety
(warnings/precautions/contra-indications)
and, where appropriate, training to users.
16 Manufacturers shall inform users of any
residual risks.
17 SPR 5: Risks In eliminating or reducing risks related to
related to use use error, the manufacturer shall:
18 (a) reduce as far as possible the risks
related to the ergonomic features of the
device and the environment in which the
device is intended to be used (design for
patient safety), and
19 (b) give consideration to the technical
knowledge, experience, education,
training and use environment, where
applicable, and the medical and physical
conditions of intended users (design for
lay, professional, disabled or other users).
20 SPR 6: Device I.6. The characteristics and performance of

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lifetime a device shall not be adversely affected to
such a degree that the health or safety of
the patient or the user and, where
applicable, of other persons are
compromised during the lifetime of the
device, as indicated by the manufacturer,
when the device is subjected to the
stresses which can occur during normal
conditions of use and has been properly
maintained in accordance with the
manufacturer's instructions.
21 SPR 7: Packaging, I.7 Devices shall be designed,
transport, manufactured and packaged in such a way
storage that their characteristics and performance
during their intended use are not
adversely affected during transport and
storage, for example, through fluctuations
of temperature and humidity, taking
account of the instructions and
information provided by the
manufacturer.
22 SPR 8: Risk- I.8. All known and foreseeable risks, and
benefit ratio any undesirable side-effects, shall be
minimised and be acceptable when
weighed against the evaluated benefits to

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the patient and/or user arising from the
achieved performance of the device
during normal conditions of use.
23 SPR 9: Devices I.9. For the devices referred to in Annex
without a XVI, the general safety requirements set
medical purpose out in Sections 1 and 8 shall be
understood to mean that the device, when
used under the conditions and for the
purposes intended, does not present a risk
at all or presents a risk that is no more
than the maximum acceptable risk related
to the product's use which is consistent
with a high level of protection for the
safety and health of persons.
24 CHAPTER II: REQUIREMENTS REGARDING
DESIGN AND MANUFACTURE
25 SPR 10: Chemical, II.10. Chemical, physical and biological
physical and properties
biological
properties
26 SPR 10.1: General II.10.1. Devices shall be designed and
considerations manufactured in such a way as to ensure
for materials that the characteristics and performance
requirements referred to in Chapter I are
fulfilled. Particular attention shall be paid

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to:
27 (a) the choice of materials and substances
used, particularly as regards toxicity and,
where relevant, flammability;
28 (b) the compatibility between the
materials and substances used and
biological tissues, cells and body fluids,
taking account of the intended purpose of
the device and, where relevant,
absorption, distribution, metabolism and
excretion;
29 (c) the compatibility between the different
parts of a device which consists of more
than one implantable part;
30 (d) the impact of processes on material
properties;
31 (e) where appropriate, the results of
biophysical or modelling research the
validity of which has been demonstrated
beforehand;
32 (f) the mechanical properties of the
materials used, reflecting, where
appropriate, matters such as strength,
ductility, fracture resistance, wear

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resistance and fatigue resistance;
33 (g) surface properties; and
34 (h) the confirmation that the device meets
any defined chemical and/or physical
specifications.
35 SPR 10.2: Risks II.10.2. Devices shall be designed,
from manufactured and packaged in such a way
contaminants as to minimise the risk posed by
and residues contaminants and residues to patients,
taking account of the intended purpose of
the device, and to the persons involved in
the transport, storage and use of the
devices. Particular attention shall be paid
to tissues exposed to those contaminants
and residues and to the duration and
frequency of exposure.
36 SPR 10.3: II.10.3. Devices shall be designed and
Compatibility manufactured in such a way that they can
with materials be used safely with the materials and
and substances substances, including gases, with which
they enter into contact during their
intended use;
37 if the devices are intended to administer
medicinal products they shall be designed

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and manufactured in such a way as to be
compatible with the medicinal products
concerned in accordance with the
provisions and restrictions governing
those medicinal products and that the
performance of both the medicinal
products and of the devices is maintained
in accordance with their respective
indications and intended use.

38 SPR 10.4: II.10.4. Substances

Substances
contained in and
released from
the device
39 II.10.4.1. Design and manufacture of
devices

Devices shall be designed and

manufactured in such a way as to reduce
as far as possible the risks posed by
substances or particles, including wear
debris, degradation products and
processing residues, that may be released
from the device.

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Devices, or those parts thereof or those

materials used therein that:
— are invasive and come into direct
contact with the human body,
— (re)administer medicines, body liquids
or other substances, including gases,
to/from the body, or
— transport or store such medicines, body
fluids or substances, including gases, to be
(re)administered to the body,
shall only contain the following substances
in a concentration that is above 0,1 %
weight by weight (w/w) where justified
pursuant to Section 10.4.2:
40 (a) substances which are carcinogenic,
mutagenic or toxic to reproduction
(‘CMR’), of category 1A or 1B, in
accordance with Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the
European Parliament and of the Council
(1), or
41 (b) substances having endocrine-
disrupting properties for which there is
scientific evidence of probable serious

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effects to human health and which are
identified either in accordance with the
procedure set out in Article 59 of
Regulation (EC) No 1907/2006 of the
European Parliament and of the Council
(2) or, once a delegated act has been
adopted by the Commission pursuant to
the first subparagraph of Article 5(3) of
Regulation (EU) No 528/2012 of the
European Parliament and the Council (3),
in accordance with the criteria that are
relevant to human health amongst the
criteria established therein.
42 II.10.4.2. Justification regarding the
presence of CMR and/or endocrine-
disrupting substances
The justification for the presence of such
substances shall be based upon:
43 (a) an analysis and estimation of potential
patient or user exposure to the
substance;
44 (b) an analysis of possible alternative
substances, materials or designs,
including, where available, information
about independent research, peer-

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reviewed studies, scientific opinions from
relevant scientific committees and an
analysis of the availability of such
alternatives;
45 (c) argumentation as to why possible
substance and/ or material substitutes, if
available, or design changes, if feasible,
are inappropriate in relation to
maintaining the functionality,
performance and the benefit-risk ratios of
the product; including taking into account
if the intended use of such devices
includes treatment of children or
treatment of pregnant or breastfeeding
women or treatment of other patient
groups considered particularly vulnerable
to such substances and/or materials; and
46 (d) where applicable and available, the
latest relevant scientific committee
guidelines in accordance with Sections
10.4.3. and 10.4.4.
47 II.10.4.3. Guidelines on phthalates
For the purposes of Section 10.4., the
Commission shall, as soon as possible and
by 26 May 2018, provide the relevant

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scientific committee with a mandate to
prepare guidelines that shall be ready
before 26 May 2020. The mandate for the
committee shall encompass at least a
benefit-risk assessment of the presence of
phthalates which belong to either of the
groups of substances referred to in points
(a) and (b) of Section 10.4.1. The benefit-
risk assessment shall take into account the
intended purpose and context of the use
of the device, as well as any available
alternative substances and alternative
materials, designs or medical treatments.
When deemed appropriate on the basis of
the latest scientific evidence, but at least
every five years, the guidelines shall be
updated.
48 II.10.4.4. Guidelines on other CMR and
endocrine-disrupting substances
Subsequently, the Commission shall
mandate the relevant scientific committee
to prepare guidelines as referred to in
Section 10.4.3. also for other substances
referred to in points (a) and (b) of Section
10.4.1., where appropriate.

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49 II.10.4.5. Labelling
Where devices, parts thereof or materials
used therein as referred to in Section
10.4.1. contain substances referred to in
points (a) or (b) of Section 10.4.1. in a
concentration above 0,1 % weight by
weight (w/w), the presence of those
substances shall be labelled on the device
itself and/or on the packaging for each
unit or, where appropriate, on the sales
packaging, with the list of such substances.
If the intended use of such devices
includes treatment of children or
treatment of pregnant or breastfeeding
women or treatment of other patient
groups considered particularly vulnerable
to such substances and/or materials,
information on residual risks for those
patient groups and, if applicable, on
appropriate precautionary measures shall
be given in the instructions for use.
50 SPR 10.5: Risk of II.10.5. Devices shall be designed and
unintentional manufactured in such a way as to reduce
ingress as far as possible the risks posed by the
unintentional ingress of substances into

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the device taking into account the device
and the nature of the environment in
which it is intended to be used.
51 SPR 10.6: Risks II.10.6. Devices shall be designed and
related to manufactured in such a way as to reduce
particle size as far as possible the risks linked to the
size and the properties of particles which
are or can be released into the patient's or
user's body, unless they come into contact
with intact skin only. Special attention
shall be given to nanomaterials.
52 II.11. Infection and microbial
contamination
53 SPR 11.1: Risk of II.11.1. Devices and their manufacturing
infection processes shall be designed in such a way
as to eliminate or to reduce as far as
possible the risk of infection to patients,
users and, where applicable, other
persons. The design shall:
(a) reduce as far as possible and
appropriate the risks from unintended
cuts and pricks, such as needle stick
injuries,
(b) allow easy and safe handling,
(c) reduce as far as possible any microbial

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leakage from the device and/or microbial
exposure during use, and
(d) prevent microbial contamination of the
device or its content such as specimens or
fluids.
54 SPR 11.2: Design II.11.2. Where necessary devices shall be
for reuse designed to facilitate their safe cleaning,
disinfection, and/or re-sterilisation.
55 SPR 11.3: Devices II.11.3. Devices labelled as having a
with a specific specific microbial state shall be designed,
microbial state manufactured and packaged to ensure
that they remain in that state when placed
on the market and remain so under the
transport and storage conditions specified
by the manufacturer.
56 SPR 11.4: Devices II.11.4. Devices delivered in a sterile state
delivered sterile shall be designed, manufactured and
packaged in accordance with appropriate
procedures, to ensure that they are sterile
when placed on the market and that,
unless the packaging which is intended to
maintain their sterile condition is
damaged, they remain sterile, under the
transport and storage conditions specified
by the manufacturer, until that packaging

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is opened at the point of use. It shall be
ensured that the integrity of that
packaging is clearly evident to the final
user.
57 SPR 11.5: II.11.5. Devices labelled as sterile shall be
Validation for processed, manufactured, packaged and,
sterile devices sterilised by means of appropriate,
validated methods.
58 SPR 11.6: II.11.6. Devices intended to be sterilised
Environmental shall be manufactured and packaged in
controls appropriate and controlled conditions and
facilities.
59 SPR 11.7: II.11.7. Packaging systems for non-sterile
Packaging for devices shall maintain the integrity and
non-sterile cleanliness of the product and, where the
devices devices are to be sterilised prior to use,
minimise the risk of microbial
contamination; the packaging system shall
be suitable taking account of the method
of sterilisation indicated by the
manufacturer.
60 SPR 11.8: II.11.8. The labelling of the device shall
Labelling for distinguish between identical or similar
sterile state devices placed on the market in both a
sterile and a non-sterile condition

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additional to the symbol used to indicate
that devices are sterile.
61 SPR 12: Devices II.12. Devices incorporating a substance
incorporating a considered to be a medicinal product and
medicinal devices that are composed of substances
product; or of combinations of substances that are
substances absorbed by or locally dispersed in the
absorbed or human body.
locally dispersed
62 SPR 12.1: Devices II.12.1. In the case of devices referred to in
incorporating a the first subparagraph of Article 1(8), the
medicinal quality, safety and usefulness of the
product substance which, if used separately, would
be considered to be a medicinal product
within the meaning of point (2) of Article 1
of Directive 2001/83/EC, shall be verified
by analogy with the methods specified in
Annex I to Directive 2001/83/EC, as
required by the applicable conformity
assessment procedure under this
Regulation.
63 SPR 12.2: Devices II.12.2. Devices that are composed of
composed of substances or of combinations of
substances substances that are intended to be
absorbed or introduced into the human body, and that

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locally are absorbed by or locally dispersed in the
dispersed human body shall comply, where
applicable and in a manner limited to the
aspects not covered by this Regulation,
with the relevant requirements laid down
in Annex I to Directive 2001/83/EC for the
evaluation of absorption, distribution,
metabolism, excretion, local tolerance,
toxicity, interaction with other devices,
medicinal products or other substances
and potential for adverse reactions, as
required by the applicable conformity
assessment procedure under this
Regulation.
64 SPR 13: Devices II.13. Devices incorporating materials of
incorporating biological origin
materials of
biological origin
65 SPR 13.1: Tissues, II.13.1. For devices manufactured utilising
cells or derivatives of tissues or cells of human
derivatives of origin which are non-viable or are
human origin rendered non-viable covered by this
Regulation in accordance with point (g) of
Article 1(6), the following shall apply:
66 (a) donation, procurement and testing of

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the tissues and cells shall be done in
accordance with Directive 2004/23/EC;
67 (b) processing, preservation and any other
handling of those tissues and cells or their
derivatives shall be carried out so as to
provide safety for patients, users and,
where applicable, other persons. In
particular, safety with regard to viruses
and other transmissible agents shall be
addressed by appropriate methods of
sourcing and by implementation of
validated methods of elimination or
inactivation in the course of the
manufacturing process;
68 (c) the traceability system for those
devices shall be complementary and
compatible with the traceability and data
protection requirements laid down in
Directive 2004/23/EC and in Directive
2002/98/EC.
69 SPR 13.2: Tissues, II.13.2. For devices manufactured utilising
cells or tissues or cells of animal origin, or their
derivatives of derivatives, which are non-viable or
animal origin rendered non-viable the following shall
apply:

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70 (a) where feasible taking into account the
animal species, tissues and cells of animal
origin, or their derivatives, shall originate
from animals that have been subjected to
veterinary controls that are adapted to the
intended use of the tissues. Information
on the geographical origin of the animals
shall be retained by manufacturers;
71 (b) sourcing, processing, preservation,
testing and handling of tissues, cells and
substances of animal origin, or their
derivatives, shall be carried out so as to
provide safety for patients, users and,
where applicable, other persons. In
particular safety with regard to viruses and
other transmissible agents shall be
addressed by implementation of validated
methods of elimination or viral
inactivation in the course of the
manufacturing process, except when the
use of such methods would lead to
unacceptable degradation compromising
the clinical benefit of the device;
72 (c) in the case of devices manufactured
utilising tissues or cells of animal origin, or

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their derivatives, as referred to in
Regulation (EU) No 722/2012 the
particular requirements laid down in that
Regulation shall apply.
73 SPR 13.3: Other II.13.3. For devices manufactured utilising
non-viable non-viable biological substances other
biological than those referred to in Sections 13.1 and
substances 13.2, the processing, preservation, testing
and handling of those substances shall be
carried out so as to provide safety for
patients, users and, where applicable,
other persons, including in the waste
disposal chain. In particular, safety with
regard to viruses and other transmissible
agents shall be addressed by appropriate
methods of sourcing and by
implementation of validated methods of
elimination or inactivation in the course of
the manufacturing process.
74 SPR 14: II.14. Construction of devices and
Construction of interaction with their environment
devices and
interaction with
their
environment

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75 SPR 14.1: Use in II.14.1. If the device is intended for use in
combination combination with other devices or
equipment the whole combination,
including the connection system shall be
safe and shall not impair the specified
performance of the devices. Any
restrictions on use applying to such
combinations shall be indicated on the
label and/or in the instructions for use.
Connections which the user has to handle,
such as fluid, gas transfer, electrical or
mechanical coupling, shall be designed
and constructed in such a way as to
minimise all possible risks, such as
misconnection.
76 SPR 14.2: Risks of II.14.2. Devices shall be designed and
interaction with manufactured in such a way as to remove
the environment or reduce as far as possible:
77 (a) the risk of injury, in connection with
their physical features, including the
volume/pressure ratio, dimensional and
where appropriate ergonomic features;
78 (b) risks connected with reasonably
foreseeable external influences or
environmental conditions, such as

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magnetic fields, external electrical and
electromagnetic effects, electrostatic
discharge, radiation associated with
diagnostic or therapeutic procedures,
pressure, humidity, temperature,
variations in pressure and acceleration or
radio signal interferences;
79 (c) the risks associated with the use of the
device when it comes into contact with
materials, liquids, and substances,
including gases, to which it is exposed
during normal conditions of use;
80 (d) the risks associated with the possible
negative interaction between software
and the IT environment within which it
operates and interacts;
81 (e) the risks of accidental ingress of
substances into the device;
82 (f) the risks of reciprocal interference with
other devices normally used in the
investigations or for the treatment given;
and
83 (g) risks arising where maintenance or N/A
calibration are not possible (as with

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implants), from ageing of materials used
or loss of accuracy of any measuring or
control mechanism.
84 SPR 14.3: Risks of II.14.3. Devices shall be designed and N\A
fire or explosion manufactured in such a way as to
minimise the risks of fire or explosion
during normal use and in single fault
condition. Particular attention shall be
paid to devices the intended use of which
includes exposure to or use in association
with flammable or explosive substances or
substances which could cause combustion.
85 SPR 14.4: Design II.14.4. Devices shall be designed and N\A
for adjustment, manufactured in such a way that
calibration and adjustment, calibration, and maintenance
maintenance can be done safely and effectively.
86 SPR 14.5: Design II.14.5. Devices that are intended to be N\A
for compatibility operated together with other devices or
products shall be designed and
manufactured in such a way that the
interoperability and compatibility are
reliable and safe.
87 SPR 14.6: II.14.6. Any measurement, monitoring or
Measurement, display scale shall be designed and
monitoring or manufactured in line with ergonomic

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display scales principles, taking account of the intended
purpose, users and the environmental
conditions in which the devices are
intended to be used.
88 SPR 14.7: Design II.14.7. Devices shall be designed and
and manufacture manufactured in such a way as to facilitate
for safe disposal their safe disposal and the safe disposal of
related waste substances by the user,
patient or other person. To that end,
manufacturers shall identify and test
procedures and measures as a result of
which their devices can be safely disposed
after use. Such procedures shall be
described in the instructions for use.
89 SPR 15: Devices II.15. Devices with a diagnostic or
with a diagnostic measuring function
or measuring
function
90 II.15.1. Diagnostic devices and devices
with a measuring function, shall be
designed and manufactured in such a way
as to provide sufficient accuracy, precision
and stability for their intended purpose,
based on appropriate scientific and
technical methods. The limits of accuracy

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shall be indicated by the manufacturer.
91 II.15.2. The measurements made by
devices with a measuring function shall be
expressed in legal units conforming to the
provisions of Council Directive
80/181/EEC.
92 SPR 16: II.16. Protection against radiation
Protection
against radiation
93 II.16.1. General
94 (a) Devices shall be designed,
manufactured and packaged in such a way
that exposure of patients, users and other
persons to radiation is reduced as far as
possible, and in a manner that is
compatible with the intended purpose,
whilst not restricting the application of
appropriate specified levels for
therapeutic and diagnostic purposes.
95 (b) The operating instructions for devices
emitting hazardous or potentially
hazardous radiation shall contain detailed
information as to the nature of the
emitted radiation, the means of protecting

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the patient and the user, and on ways of
avoiding misuse and of reducing the risks
inherent to installation as far as possible
and appropriate. Information regarding
the acceptance and performance testing,
the acceptance criteria, and the
maintenance procedure shall also be
specified.
96 II.16.2. Intended radiation
97 (a) Where devices are designed to emit
hazardous, or potentially hazardous, levels
of ionizing and/or non- ionizing radiation
necessary for a specific medical purpose
the benefit of which is considered to
outweigh the risks inherent to the
emission, it shall be possible for the user
to control the emissions. Such devices
shall be designed and manufactured to
ensure reproducibility of relevant variable
parameters within an acceptable
tolerance.
98 (b) Where devices are intended to emit
hazardous, or potentially hazardous,
ionizing and/or non-ionizing radiation,
they shall be fitted, where possible, with

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visual displays and/or audible warnings of
such emissions.
99 II.16.3. Devices shall be designed and
manufactured in such a way that exposure
of patients, users and other persons to the
emission of unintended, stray or scattered
radiation is reduced as far as possible.
Where possible and appropriate, methods
shall be selected which reduce the
exposure to radiation of patients, users
and other persons who may be affected.
10 II.16.4. Ionising radiation
0
10 (a) Devices intended to emit ionizing
1 radiation shall be designed and
manufactured taking into account the
requirements of the Directive
2013/59/Euratom laying down basic safety
standards for protection against the
dangers arising from exposure to ionising
radiation.
10 (b) Devices intended to emit ionising
2 radiation shall be designed and
manufactured in such a way as to ensure
that, where possible, taking into account

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the intended use, the quantity, geometry
and quality of the radiation emitted can be
varied and controlled, and, if possible,
monitored during treatment.
10 (c) Devices emitting ionising radiation
3 intended for diagnostic radiology shall be
designed and manufactured in such a way
as to achieve an image and/or output
quality that are appropriate to the
intended medical purpose whilst
minimising radiation exposure of the
patient and user.
10 (d) Devices that emit ionising radiation and
4 are intended for therapeutic radiology
shall be designed and manufactured in
such a way as to enable reliable
monitoring and control of the delivered
dose, the beam type, energy and, where
appropriate, the quality of radiation.
10 SPR 17: II.17. Electronic programmable systems —
5 Electronic devices that incorporate electronic
programmable programmable systems and software that
systems and are devices in themselves
software
10 II.17.1. Devices that incorporate electronic

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6 programmable systems, including
software, or software that are devices in
themselves, shall be designed to ensure
repeatability, reliability and performance
in line with their intended use. In the
event of a single fault condition,
appropriate means shall be adopted to
eliminate or reduce as far as possible
consequent risks or impairment of
performance.
10 II.17.2. For devices that incorporate
7 software or for software that are devices
in themselves, the software shall be
developed and manufactured in
accordance with the state of the art taking
into account the principles of
development life cycle, risk management,
including information security, verification
and validation.
10 II.17.3. Software referred to in this Section
8 that is intended to be used in combination
with mobile computing platforms shall be
designed and manufactured taking into
account the specific features of the mobile
platform (e.g. size and contrast ratio of the

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screen) and the external factors related to
their use (varying environment as regards
level of light or noise).
10 II.17.4. Manufacturers shall set out
9 minimum requirements concerning
hardware, IT networks characteristics and
IT security measures, including protection
against unauthorised access, necessary to
run the software as intended.
11 SPR 18: Active II.18. Active devices and devices
0 devices and connected to them
devices
connected to
them
11 II.18.1. For non-implantable active devices,
1 in the event of a single fault condition,
appropriate means shall be adopted to
eliminate or reduce as far as possible
consequent risks.
11 II.18.2. Devices where the safety of the
2 patient depends on an internal power
supply shall be equipped with a means of
determining the state of the power supply
and an appropriate warning or indication
for when the capacity of the power supply

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becomes critical. If necessary, such
warning or indication shall be given prior
to the power supply becoming critical.
11 II.18.3. Devices where the safety of the
3 patient depends on an external power
supply shall include an alarm system to
signal any power failure.
11 II.18.4. Devices intended to monitor one
4 or more clinical parameters of a patient
shall be equipped with appropriate alarm
systems to alert the user of situations
which could lead to death or severe
deterioration of the patient's state of
health.
11 II.18.5. Devices shall be designed and
5 manufactured in such a way as to reduce
as far as possible the risks of creating
electromagnetic interference which could
impair the operation of the device in
question or other devices or equipment in
the intended environment.
11 II.18.6. Devices shall be designed and
6 manufactured in such a way as to provide
a level of intrinsic immunity to
electromagnetic interference such that is

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adequate to enable them to operate as
intended.
11 II.18.7. Devices shall be designed and
7 manufactured in such a way as to avoid, as
far as possible, the risk of accidental
electric shocks to the patient, user or any
other person, both during normal use of
the device and in the event of a single
fault condition in the device, provided the
device is installed and maintained as
indicated by the manufacturer.
11 II.18.8. Devices shall be designed and
8 manufactured in such a way as to protect,
as far as possible, against unauthorised
access that could hamper the device from
functioning as intended.
11 SPR 19: Particular II.19. Particular requirements for active
9 requirements for implantable devices
active
implantable
devices
12 SPR 19.1: II.19.1. Active implantable devices shall be
0 Particular risks to designed and manufactured in such a way
be reduced for as to remove or minimize as far as
active possible:

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implantable
devices
12 (a) risks connected with the use of energy
1 sources with particular reference, where
electricity is used, to insulation, leakage
currents and overheating of the devices,
12 (b) risks connected with medical
2 treatment, in particular those resulting
from the use of defibrillators or high-
frequency surgical equipment, and
12 (c) risks which may arise where
3 maintenance and calibration are
impossible, including:
— excessive increase of leakage currents,
— ageing of the materials used,
— excess heat generated by the device,
— decreased accuracy of any measuring or
control mechanism.
12 SPR 19.2: Device II.19.2. Active implantable devices shall be
4 compatibility and designed and manufactured in such a way
reliability of as to ensure
energy — if applicable, the compatibility of the
devices with the substances they are
intended to administer, and
— the reliability of the source of energy.

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12 SPR 19.3: II.19.3. Active implantable devices and, if
5 Identification of appropriate, their component parts shall
devices and be identifiable to allow any necessary
components measure to be taken following the
discovery of a potential risk in connection
with the devices or their component parts.
12 SPR 19.4: II.19.4. Active implantable devices shall
6 Identification bear a code by which they and their
code manufacturer can be unequivocally
identified (particularly with regard to the
type of device and its year of
manufacture); it shall be possible to read
this code, if necessary, without the need
for a surgical operation.
12 SPR 20: II.20. Protection against mechanical and
7 Protection thermal risks
against
mechanical and
thermal risks
12 II.20.1. Devices shall be designed and
8 manufactured in such a way as to protect
patients and users against mechanical risks
connected with, for example, resistance to
movement, instability and moving parts.
12 II.20.2. Devices shall be designed and

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9 manufactured in such a way as to reduce
to the lowest possible level the risks
arising from vibration generated by the
devices, taking account of technical
progress and of the means available for
limiting vibrations, particularly at source,
unless the vibrations are part of the
specified performance.
13 II.20.3. Devices shall be designed and
0 manufactured in such a way as to reduce
to the lowest possible level the risks
arising from the noise emitted, taking
account of technical progress and of the
means available to reduce noise,
particularly at source, unless the noise
emitted is part of the specified
performance.
13 II.20.4. Terminals and connectors to the
1 electricity, gas or hydraulic and pneumatic
energy supplies which the user or other
person has to handle, shall be designed
and constructed in such a way as to
minimise all possible risks.
13 II.20.5. Errors likely to be made when
2 fitting or refitting certain parts which could

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be a source of risk shall be made
impossible by the design and construction
of such parts or, failing this, by
information given on the parts themselves
and/or their housings.

The same information shall be given on

moving parts and/or their housings where
the direction of movement needs to be
known in order to avoid a risk.
13 II.20.6. Accessible parts of devices
3 (excluding the parts or areas intended to
supply heat or reach given temperatures)
and their surroundings shall not attain
potentially dangerous temperatures under
normal conditions of use.
13 SPR 21: II.21. Protection against the risks posed to
4 Protection the patient or user by devices supplying
against the risks energy or substances
posed to the
patient or user by
devices supplying
energy or
substances
13 II.21.1. Devices for supplying the patient

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5 with energy or substances shall be
designed and constructed in such a way
that the amount to be delivered can be set
and maintained accurately enough to
ensure the safety of the patient and of the
user.
13 II.21.2. Devices shall be fitted with the
6 means of preventing and/or indicating any
inadequacies in the amount of energy
delivered or substances delivered which
could pose a danger.
13 Devices shall incorporate suitable means
7 to prevent, as far as possible, the
accidental release of dangerous levels of
energy or substances from an energy
and/or substance source.
13 II.21.3. The function of the controls and
8 indicators shall be clearly specified on the
devices.
13 Where a device bears instructions
9 required for its operation or indicates
operating or adjustment parameters by
means of a visual system, such
information shall be understandable to the
user and, as appropriate, the patient.

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14 SPR 22: II.22. Protection against the risks posed by
0 Protection medical devices intended by the
against the risks manufacturer for use by lay persons
posed by medical
devices intended
by the
manufacturer for
use by lay
persons
14 II.22.1. Devices for use by lay persons shall
1 be designed and manufactured in such a
way that they perform appropriately for
their intended purpose taking into account
the skills and the means available to lay
persons and the influence resulting from
variation that can be reasonably
anticipated in the lay person's technique
and environment. The information and
instructions provided by the manufacturer
shall be easy for the lay person to
understand and apply.
14 II.22.2. Devices for use by lay persons shall
2 be designed and manufactured in such a
way as to:
— ensure that the device can be used

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safely and accurately by the intended user
at all stages of the procedure, if necessary
after appropriate training and/or
information,
— reduce, as far as possible and
appropriate, the risk from unintended cuts
and pricks such as needle stick injuries,
and
— reduce as far as possible the risk of
error by the intended user in the handling
of the device and, if applicable, in the
interpretation of the results.
14 II.22.3. Devices for use by lay persons
3 shall, where appropriate, include a
procedure by which the lay person:
— can verify that, at the time of use, the
device will perform as intended by the
manufacturer, and
— if applicable, is warned if the device has
failed to provide a valid result.
14 CHAPTER III: REQUIREMENTS REGARDING
4 THE INFORMATION SUPPLIED WITH THE
DEVICE
14 SPR 23: Label and III.23. Label and instructions for use
5 instructions for

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use
14 SPR 23.1: General III.23.1. General requirements regarding
6 requirements for the information supplied by the
information manufacturer
supplied by the
manufacturer Each device shall be accompanied by the
information needed to identify the device
and its manufacturer, and by any safety
and performance information relevant to
the user, or any other person, as
appropriate. Such information may appear
on the device itself, on the packaging or in
the instructions for use, and shall, if the
manufacturer has a website, be made
available and kept up to date on the
website, taking into account the following:
14 (a) The medium, format, content,
7 legibility, and location of the label and
instructions for use shall be appropriate to
the particular device, its intended purpose
and the technical knowledge, experience,
education or training of the intended
user(s). In particular, instructions for use
shall be written in terms readily
understood by the intended user and,

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where appropriate, supplemented with
drawings and diagrams.
14 (b) The information required on the label
8 shall be provided on the device itself. If
this is not practicable or appropriate,
some or all of the information may appear
on the packaging for each unit, and/or on
the packaging of multiple devices.
14 (c) Labels shall be provided in a human-
9 readable format and may be
supplemented by machine-readable
information, such as radio-frequency
identification (‘RFID’) or bar codes.
15 (d) Instructions for use shall be provided
0 together with devices. By way of
exception, instructions for use shall not be
required for class I and class IIa devices if
such devices can be used safely without
any such instructions and unless otherwise
provided for elsewhere in this Section.

15 (e) Where multiple devices are supplied to

1 a single user and/or location, a single copy
of the instructions for use may be
provided if so agreed by the purchaser

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who in any case may request further
copies to be provided free of charge.

15 (f) Instructions for use may be provided to

2 the user in non-paper format (e.g.
electronic) to the extent, and only under
the conditions, set out in Regulation (EU)
No 207/2012 or in any subsequent
implementing rules adopted pursuant to
this Regulation.
15 (g) Residual risks which are required to be
3 communicated to the user and/or other
person shall be included as limitations,
contra-indications, precautions or
warnings in the information supplied by
the manufacturer.
15 (h) Where appropriate, the information
4 supplied by the manufacturer shall take
the form of internationally recognised
symbols. Any symbol or identification
colour used shall conform to the
harmonised standards or CS. In areas for
which no harmonised standards or CS
exist, the symbols and colours shall be
described in the documentation supplied

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with the device.
15 SPR 23.2: Label III.23.2. Information on the label
5 requirements The label shall bear all of the following
particulars:
15 (a) the name or trade name of the device;
6
15 (b) the details strictly necessary for a user
7 to identify the device, the contents of the
packaging and, where it is not obvious for
the user, the intended purpose of the
device;
15 (c) the name, registered trade name or
8 registered trademark of the manufacturer
and the address of its registered place of
business;
15 (d) if the manufacturer has its registered
9 place of business outside the Union, the
name of the authorised representative
and address of the registered place of
business of the authorised representative;
16 (e) where applicable, an indication that
0 the device contains or incorporates:
— a medicinal substance, including a
human blood or plasma derivative, or

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— tissues or cells, or their derivatives, of
human origin, or
— tissues or cells of animal origin, or their
derivatives, as referred to in Regulation
(EU) No 722/2012;
16 (f) where applicable, information labelled
1 in accordance with Section 10.4.5.;
16 (g) the lot number or the serial number of
2 the device preceded by the words LOT
NUMBER or SERIAL NUMBER or an
equivalent symbol, as appropriate;
16 (h) the UDI carrier referred to in Article
3 27(4) and Part C of Annex VII;
16 (i) an unambiguous indication of the time
4 limit for using or implanting the device
safely, expressed at least in terms of year
and month, where this is relevant;
16 (j) where there is no indication of the date
5 until when it may be used safely, the date
of manufacture. This date of manufacture
may be included as part of the lot number
or serial number, provided the date is
clearly identifiable;
16 (k) an indication of any special storage

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6 and/or handling condition that applies;
16 (l) if the device is supplied sterile, an
7 indication of its sterile state and the
sterilisation method;
16 (m) warnings or precautions to be taken
8 that need to be brought to the immediate
attention of the user of the device, and to
any other person. This information may be
kept to a minimum in which case more
detailed information shall appear in the
instructions for use, taking into account
the intended users;
16 (n) if the device is intended for single use,
9 an indication of that fact. A
manufacturer's indication of single use
shall be consistent across the Union;
17 (o) if the device is a single-use device that
0 has been reprocessed, an indication of
that fact, the number of reprocessing
cycles already performed, and any
limitation as regards the number of
reprocessing cycles;
17 (p) if the device is custom-made, the
1 words ‘custom-made device’;

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17 (q) an indication that the device is a
2 medical device. If the device is intended
for clinical investigation only, the words
‘exclusively for clinical investigation’;
17 (r) in the case of devices that are
3 composed of substances or of
combinations of substances that are
intended to be introduced into the human
body via a body orifice or applied to the
skin and that are absorbed by or locally
dispersed in the human body, the overall
qualitative composition of the device and
quantitative information on the main
constituent or constituents responsible for
achieving the principal intended action;
17 (s) for active implantable devices, the
4 serial number, and for other implantable
devices, the serial number or the lot
number.
17 SPR 23.3: Sterile III.23.3. Information on the packaging
5 package label which maintains the sterile condition of a
requirements device (‘sterile packaging’)
The following particulars shall appear on
the sterile packaging:
17 (a) an indication permitting the sterile

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6 packaging to be recognised as such,
17 (b) a declaration that the device is in a
7 sterile condition,
17 (c) the method of sterilisation,
8
17 (d) the name and address of the
9 manufacturer,
18 (e) a description of the device,
0
18 (f) if the device is intended for clinical
1 investigations, the words ‘exclusively for
clinical investigations’,
18 (g) if the device is custom-made, the
2 words ‘custom-made device’,
18 (h) the month and year of manufacture,
3
18 (i) an unambiguous indication of the time
4 limit for using or implanting the device
safely expressed at least in terms of year
and month, and
18 (j) an instruction to check the instructions
5 for use for what to do if the sterile
packaging is damaged or unintentionally
opened before use.

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18 SPR 23.4: III.23.4. Information in the instructions for
6 Instructions for use
Use The instructions for use shall contain all of
the following particulars:
18 (a) the particulars referred to in points (a),
7 (c), (e), (f), (k), (l), (n) and (r) of Section
23.2;
18 (b) the device's intended purpose with a
8 clear specification of indications, contra-
indications, the patient target group or
groups, and of the intended users, as
appropriate;
18 (c) where applicable, a specification of the
9 clinical benefits to be expected.
19 (d) where applicable, links to the summary
0 of safety and clinical performance referred
to in Article 32;
19 (e) the performance characteristics of the
1 device;
19 (f) where applicable, information allowing
2 the healthcare professional to verify if the
device is suitable and select the
corresponding software and accessories;
19 (g) any residual risks, contra-indications

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3 and any undesirable side-effects, including
information to be conveyed to the patient
in this regard;
19 (h) specifications the user requires to use N\A
4 the device appropriately, e.g. if the device
has a measuring function, the degree of
accuracy claimed for it;
19 (i) details of any preparatory treatment or
5 handling of the device before it is ready
for use or during its use, such as
sterilisation, final assembly, calibration,
etc., including the levels of disinfection
required to ensure patient safety and all
available methods for achieving those
levels of disinfection;
19 (j) any requirements for special facilities,
6 or special training, or particular
qualifications of the device user and/or
other persons;
19 (k) the information needed to verify
7 whether the device is properly installed
and is ready to perform safely and as
intended by the manufacturer, together
with, where relevant:
— details of the nature, and frequency, of

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preventive and regular maintenance, and
of any preparatory cleaning or
disinfection,
— identification of any consumable
components and how to replace them,
— information on any necessary
calibration to ensure that the device
operates properly and safely during its
intended lifetime, and
— methods for eliminating the risks
encountered by persons involved in
installing, calibrating or servicing devices;
19 (l) if the device is supplied sterile,
8 instructions in the event of the sterile
packaging being damaged or
unintentionally opened before use;
19 (m) if the device is supplied non-sterile
9 with the intention that it is sterilised
before use, the appropriate instructions
for sterilisation;
20 (n) if the device is reusable, information
0 on the appropriate processes for allowing
reuse, including cleaning, disinfection,
packaging and, where appropriate, the
validated method of re-sterilisation

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documents
appropriate to the Member State or
Member States in which the device has
been placed on the market. Information
shall be provided to identify when the
device should no longer be reused, e.g.
signs of material degradation or the
maximum number of allowable reuses;
20 (o) an indication, if appropriate, that a
1 device can be reused only if it is
reconditioned under the responsibility of
the manufacturer to comply with the
general safety and performance
requirements;
20 (p) if the device bears an indication that it
2 is for single use, information on known
characteristics and technical factors
known to the manufacturer that could
pose a risk if the device were to be re-
used. This information shall be based on a
specific section of the manufacturer's risk
management documentation, where such
characteristics and technical factors shall
be addressed in detail. If in accordance
with point (d) of Section 23.1. no
instructions for use are required, this

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information shall be made available to the
user upon request;
20 (q) for devices intended for use together
3 with other devices and/or general purpose
equipment:
— information to identify such devices or
equipment, in order to obtain a safe
combination, and/or
— information on any known restrictions
to combinations of devices and
equipment;
20 (r) if the device emits radiation for medical
4 purposes:
— detailed information as to the nature,
type and where appropriate, the intensity
and distribution of the emitted radiation,
— the means of protecting the patient,
user, or other person from unintended
radiation during use of the device;
20 (s) information that allows the user and/or
5 patient to be informed of any warnings,
precautions, contra- indications, measures
to be taken and limitations of use
regarding the device. That information
shall, where relevant, allow the user to

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 GSPR Checklist

# Requirements Requirements Applicable Applied standards, Detailed indication of Complied with

yes / no Common Specifications, supporting documents and yes / no
other speciation methods used.
documents
brief the patient about any warnings,
precautions, contra-indications, measures
to be taken and limitations of use
regarding the device. The information shall
cover, where appropriate:
— warnings, precautions and/or measures
to be taken in the event of malfunction of
the device or changes in its performance
that may affect safety,
— warnings, precautions and/or measures
to be taken as regards the exposure to
reasonably foreseeable external influences
or environmental conditions, such as
magnetic fields, external electrical and
electromagnetic effects, electrostatic
discharge, radiation associated with
diagnostic or therapeutic procedures,
pressure, humidity, or temperature
— warnings, precautions and/or measures
to be taken as regards the risks of
interference posed by the reasonably
foreseeable presence of the device during
specific diagnostic investigations,
evaluations, or therapeutic treatment or
other procedures such as electromagnetic

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 GSPR Checklist

# Requirements Requirements Applicable Applied standards, Detailed indication of Complied with

yes / no Common Specifications, supporting documents and yes / no
other speciation methods used.
documents
interference emitted by the device
affecting other equipment,
— if the device is intended to administer
medicinal products, tissues or cells of
human or animal origin, or their
derivatives, or biological substances, any
limitations or incompatibility in the choice
of substances to be delivered,
— warnings, precautions and/or
limitations related to the medicinal
substance or biological material that is
incorporated into the device as an integral
part of the device; and
— precautions related to materials
incorporated into the device that contain
or consist of CMR substances or
endocrine-disrupting substances, or that
could result in sensitisation or an allergic
reaction by the patient or user;
20 (t) in the case of devices that are
6 composed of substances or of
combinations of substances that are
intended to be introduced into the human
body and that are absorbed by or locally
dispersed in the human body, warnings

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 GSPR Checklist

# Requirements Requirements Applicable Applied standards, Detailed indication of Complied with

yes / no Common Specifications, supporting documents and yes / no
other speciation methods used.
documents
and precautions, where appropriate,
related to the general profile of
interaction of the device and its products
of metabolism with other devices,
medicinal products and other substances
as well as contra- indications, undesirable
side-effects and risks relating to overdose;
20 (u) in the case of implantable devices, the
7 overall qualitative and quantitative
information on the materials and
substances to which patients can be
exposed;
20 (v) warnings or precautions to be taken in
8 order to facilitate the safe disposal of the
device, its accessories and the
consumables used with it, if any. This
information shall cover, where
appropriate:
— infection or microbial hazards such as
explants, needles or surgical equipment
contaminated with potentially infectious
substances of human origin, and
— physical hazards such as from sharps.
20 If in accordance with the point (d) of
9 Section 23.1 no instructions for use are

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 GSPR Checklist

# Requirements Requirements Applicable Applied standards, Detailed indication of Complied with

yes / no Common Specifications, supporting documents and yes / no
other speciation methods used.
documents
required, this information shall be made
available to the user upon request;
21 (w) for devices intended for use by lay
0 persons, the circumstances in which the
user should consult a healthcare
professional;
21 (x) for the devices covered by this
1 Regulation pursuant to Article 1(2),
information regarding the absence of a
clinical benefit and the risks related to use
of the device;
21 (y) date of issue of the instructions for use
2 or, if they have been revised, date of issue
and identifier of the latest revision of the
instructions for use;
21 (z) a notice to the user and/or patient that
3 any serious incident that has occurred in
relation to the device should be reported
to the manufacturer and the competent
authority of the Member State in which
the user and/or patient is established;
21 (aa) information to be supplied to the
4 patient with an implanted device in
accordance with Article 18;

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 GSPR Checklist

# Requirements Requirements Applicable Applied standards, Detailed indication of Complied with

yes / no Common Specifications, supporting documents and yes / no
other speciation methods used.
documents
21 (ab) for devices that incorporate electronic
5 programmable systems, including
software, or software that are devices in
themselves, minimum requirements
concerning hardware, IT networks
characteristics and IT security measures,
including protection against unauthorised
access, necessary to run the software as
intended.

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2. Reference documents or additional information

List of tables
Table 1 Signatures................................................................................................................................................................2
Table 2 Document history....................................................................................................................................................2
Table 3 GSPR Checkliste.......................................................................................................................................................3

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