CE marking with BSI:

The certification process for the Medical Devices Regulation and IVD Regulation
This guide to our certification process will take you from your application to BSI through to a CE mark
certificate being issued to your company.

Following an initial discussion with our local commercial team, you will need to submit a Company
Manufacturer Information Form; this gives BSI the information we need about your company and products in order to
applies to BSI provide an accurate proposal. Your application should include the information detailed in the appropriate
Annex of the Medical Devices Regulation (MDR) or IVD Regulation (IVDR), based on your chosen conformity
assessment route: • Annex IX section 2.1 • Annex X section 2 (MDR) • Annex XI section 6.1 (MDR) or
Annex XI section 3.1 (IVDR)

BSI will generate a proposal based on the information you include in the Company Information Form. Once
Proposal accepted, the signed proposal will form the basis of the contractual agreement between your organization
and BSI. On receipt of the signed proposal, BSI will assign you a dedicated team, including the Technical
Specialist(s) responsible for the documentation reviews, a Scheme Manager to oversee certification activities,
and a support team who will coordinate your certification. This team will remain your point of contact for all
of your current and any future regulatory and certification needs.

Application and Your Scheme Manager will review your application and resulting contract for completeness, requesting
contract review any additional information required to ensure that we assign appropriately qualified Assessors to
complete your initial certification.

A specialist Quality Management System (QMS) Assessor will be assigned to assess your system to
QMS
the QMS requirements of the Regulation through a two-stage assessment: Stage 1 will review the
Assessment
completeness of your QMS, and Stage 2 will review the effective implementation of your QMS and its
compliance to the Regulation.
Note: For devices that are sterile or end-user sterilized, additional assessment by our expert Microbiologists will be required.

The Technical Specialist(s) with the relevant product expertise will be assigned to conduct your Product
Technical Assessment. The exact details will be based on your device classification and the appropriate conformity
Documentation assessment route. Your Technical Specialist(s) will review the completeness and content of your
documentation, including any additional documents or test results that provide evidence of conformity to
the Regulation. They will ask rounds of questions where any gaps are identified. Your product(s) may be
subject to additional assessment by specialist reviewers or consultation with a Competent Authority or the
EU Commission.

Final certification Once the QMS and Product Assessments have confirmed compliance to the applicable requirements,
review your Scheme Manager will conduct a final review of the activities undertaken and, if satisfied that the
requirements are met, will prepare a certification recommendation. They will then submit the information
for final BSI Certification Decision.

Certification All BSI certification is subject to a final internal approval process, consisting of a Technical and Regulatory
Decision Compliance check and a Quality and Internal Compliance check. This allows verification of, and
consistency in, BSI certification recommendations. These final reviews are conducted by BSI staff with the
appropriate technical and compliance competence.

Certificate
Once approved, your certificates will be issued electronically to your organization
Issue
Note: As your Certification Body, BSI cannot offer consultancy advice, only auditing services.
Consultancy services are available from other independent parties.
CE marking with BSI: The details
Your application
Your application for CE marking must include the following information as per the appropriate
conformity assessment Annex of the MDR or IVDR. This information will be reviewed as part of the
QMS and Technical Documentation audits:

• Details of the legal manufacturer, including name, registered • Information on how the manufacturer will meet any vigilance
business address and the manufacturing sites covered by requirements, and explanation of how these procedures will
the QMS; be implemented;
• Details of the authorized representative, including name and • User information including IFU and labelling;
registered business address (if applicable), and details of any
subcontractors;
• Evidence of conformity to the requirements for any special
processes.
• Product details including name, classification and rationale,
accessories, description, intended use and market history (if Your devices may be subject
available) for device or device group covered by the QMS;
to additional assessment from:
• Applicable directives, regulations and standards and any test
results demonstrating conformity; A microbiologist
• Draft Declaration of Conformity for the device model A clinician
covered by the scope of the certification, as per Article 19 A statistician
(MDR), Article 17 (IVDR) and Annex IV;
A toxicologist
• Information of any application to another Notified Body for A medicinal product expert
certification of the same device(s), including application for
certification of a QMS covering this device. If you have not An animal/human derivative expert
applied to another Notified Body, please state this explicitly A software expert
in writing;
An MRI compatibility expert
• The QMS documentation, including the documents and
procedures that describe how the manufacturer will fulfil
An EU reference laboratory
the QMS requirements of the Regulations, and how they will A Competent Authority
apply them to maintain an effective and adequate QMS; The EU Commission
• Evidence of conformity to the general Safety and
Performance Requirements (SPRs);
• Risk management processes, including benefit-risk analysis;
Product Assessment
• Information on the design and manufacture of the devices,
including product and software verification and validation
processes, biocompatibility testing, stability, shelf-life and
Technical Documentation review and sampling
product lifetime; plans
• The Clinical/Performance Evaluation plan and any The requirements for Technical Documentation review will vary
procedures to maintain it (taking into account state of the based on the certificate type:
art);
• For devices assessed under a Product Specific annex, each
• The documents detailing the manufacturer’s Post-Market device will be subject to a Technical Documentation review.
Surveillance (PMS) and Post-Market Clinical Follow-up
(PMCF) or Post-Market Performance Follow up (PMPF) • For devices assessed under a Quality System-based annex,
the Technical Documentation will be subject to sampling;
procedures (if applicable), including details on how
your BSI team will request the File to be sampled.
the manufacturers will meet the requirements of the
Regulations, and the procedures that maintain the PMS and Note: There may be some additional assessments required based on your product
PMCF or PMPF systems; type and its classification, as advised by your BSI team.
Special processes within the MDR and IVDR
The table below details the additional assessments required for some product types and/or conformity assessment routes:

Device type/conformity assessment route Additional assessments required

Class III implantable devices Subject to the Clinical Evaluation Consultation Procedure, an additional assessment by
the EU Commission.

Class IIb active devices under rule 12 Subject to the Clinical Evaluation Consultation Procedure, an additional assessment by
the EU Commission.

Annex X (Type-Examination) Notified Body to get samples of the finished devices and independently test these to
recognised standards

Annex XI Part B (Product Verification) Notified Body to examine and test individual finished devices to recognised standards

Devices incorporating a medicinal substance Additional assessment by a BSI medicinal substance expert and consultation with a
Competent Authority as per Directive 2001/83/EC is required.

Devices incorporating human blood derivatives Additional assessment by a BSI medicinal substance expert and consultation with the
European Medicines Agency as per Directive 2001/83/EC is required.

Devices utilizing non-viable animal tissue/cells/ Additional assessment by a BSI animal tissue expert is required, before the co-ordinating
derivatives Competent Authority gains feedback from EU Member States as per Regulation (EU) No
722/2012.

Devices utilizing non-viable human derivatives Additional assessment by a BSI human tissue expert and consultation with a human
tissues and cells Competent Authority as per Directive 2004/23/EC is required

Devices that are composed of substances or of For Class III devices under rule 21, additional assessment by a BSI expert and consultation
combinations of substances that are absorbed by with Competent Authority as per Directive 2001/83/EC is required
or locally dispersed in the human body (rule 21)

Class D IVD devices Class D IVD devices will be assessed against the requirements of the appropriate
Common Specification, and require testing at a designated EU Reference Laboratory.

Companion Diagnostics Additional assessment by the medicinal product Competent Authority or the European
Medicines Agency is required.

Self-tests and near patient tests Where practicable, BSI may request an example of the device.

Devices with no intended medical purpose BSI will only assess devices under Annex XVI if a relevant corresponding Common
Specification is published. This excludes breast implants, which are regulated as Class III
medical devices under Directive 2003/12/EC, and some disinfectants.

Your supply chain

The MDR and IVDR both detail requirements for suppliers, subcontractors, authorized representatives
and other economic operators in your supply chain, including importers and distributors.
It’s important to note that
• Contracts and agreements with these parties are required • All critical subcontractors and some crucial suppliers
as demonstration of control of your supply chain. (depending on the nature of the materials provided) will be
listed in an appendix to the CE QMS certificate.
• All critical subcontractors are required to hold valid ISO
13485 or MDSAP certification issued by an EU Notified • BSI may carry out Unannounced Audits at the legal
Body or one of its direct subsidiaries. Some crucial suppliers manufacturer locations, or their critical subcontractors and
may require appropriate certification based on the nature crucial suppliers.
of the materials provided. If this is not the case, the critical
subcontractor or crucial supplier may be subject to a
verification audit by BSI.
Submission requirements
Language of Technical documentation
The official language of BSI is English; all submissions and test results should be in the English language. BSI may
accept the Technical Documentation in another EU language if the Competent Authority does not require Technical
Documentation to be in a prescribed language, and BSI is able to allocate the Technical Specialist(s) with the correct
competencies and language capabilities. Submissions in other languages will result in additional review time and costs
for translation which will be passed on to the applicant, and subject to BSI terms covering costs.

Submission method
For more information:
Documents should be submitted via the secure BSI document
upload portal. BSI resources
Documentation to be submitted • BSI Guide to Notified Body
Make sure you include the Technical Documentation, the

BSI/UK/068/MD/0919/en/BLD
• BSI white papers, including the following titles:
required elements of your QMS, and the signed, approved
proposal when first submitting documentation to BSI. - General Safety and Performance Requirements
Signatures should be present where required. (Annex I) in the New Medical Device Regulation
- The European Medical Devices Regulations: What are
Document format
the requirements for vigilance reporting and post-
The preferred document format is a paginated, bookmarked market surveillance?

Copyright © 2019, The British Standards Institution. All rights reserved.

PDF utilizing Optical Character Recognition (OCR, searchable
- Planning for implementation of the European Union
format).
Medical Devices Regulations – Are you prepared?
- How to prepare for and implement the upcoming
Post certification activities IVDR – Dos and Don’ts
- How to prepare for and implement the upcoming
Once you are CE certified, BSI will continue to
MDR – Dos and Don’ts
assess you through regular audits, including:
• QMS surveillance audits
Additional resources
• Technical audits for your CE certification • GHTF/IMDRF • MEDDEV

• Microbiology assessments, if applicable • NB-MED • NBOG Guidance

• Unannounced audits
• Verification of manufactured batches (Class D IVDs)

Find out more, talk to us today:

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