[Company Name]

[Company Group, Division, Location]

Document Title: Medical Device Report/Medical Device

Vigilance System
Document Number: [Document Number]
Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY

STAMP HERE

OTHER
STAMP HERE

Revision Revision DCO/ECO Revision

Level Date Number Description of Revision Author
DRAFT DD/MM/Y YY-00000 Draft Author Name
Y
1.00 DD/MM/Y YY-00000 Initial Release Author Name
Y

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] MDR/MDVS Reports
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table of Contents

1.0 Purpose..........................................................................................................................................................3

2.0 Scope.............................................................................................................................................................3

3.0 Definition Of Terms......................................................................................................................................3

3.1 Advisory Notice..................................................................................................................................3
3.2 Attachments.......................................................................................................................................3
3.3 Becomes Aware..................................................................................................................................3
3.4 Corrective Action...............................................................................................................................3
3.5 Date Event Reported..........................................................................................................................3
3.6 Date of Problem / Event.....................................................................................................................3
3.7 Device Family....................................................................................................................................3
3.8 Expected Life.....................................................................................................................................3
3.9 Incident...............................................................................................................................................3
3.10 Information Reasonably Known........................................................................................................4
3.11 Intended Purpose................................................................................................................................4
3.12 Malfunction........................................................................................................................................4
3.13 Manufacturer......................................................................................................................................4
3.14 Manufacturer Report Number............................................................................................................4
3.15 Medical Advisor.................................................................................................................................4
3.16 Medical Device Report (MDR)..........................................................................................................4
3.17 MDR Reportable Events....................................................................................................................4
3.18 Medical Devices Vigilance System (MDVS).....................................................................................4
3.19 Near Incident......................................................................................................................................5
3.20 Permanent Impairment......................................................................................................................5
3.21 Product...............................................................................................................................................5
3.22 Recall..................................................................................................................................................5
3.23 Remedial Action.................................................................................................................................5
3.24 Reporter..............................................................................................................................................5
3.25 Serious Deterioration in State of Health............................................................................................5
3.26 Serious Injury / Serious Illness..........................................................................................................5
3.27 Shelf Life............................................................................................................................................5
3.28 Single Fault Condition.......................................................................................................................5
3.29 User Error...........................................................................................................................................5
3.30 Work Day............................................................................................................................................5
3.31 References..........................................................................................................................................5

4.0 Responsibilities and Requirements...............................................................................................................6

4.1 Quality Assurance Manager...............................................................................................................6
4.2 [Employee Title], Quality Systems....................................................................................................6
4.3 Medical Advisor.................................................................................................................................6
4.4 [Company Name] Employees............................................................................................................6

5.0 MDR Reportable Events...............................................................................................................................6

5.1 Malfunction........................................................................................................................................7
5.2 Caused or Contributed.......................................................................................................................7
5.3 Reasonably Suggests..........................................................................................................................7
5.4 Concept of "may have".......................................................................................................................7

6.0 MDR Non-Reportable Events.......................................................................................................................7

7.0 Procedure......................................................................................................................................................7

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7.1 Reporter..............................................................................................................................................7
7.2 Quality Assurance..............................................................................................................................8

8.0 Types of MDR Reports..................................................................................................................................8

8.1 30-Day Report....................................................................................................................................9
8.2 5-Day Report......................................................................................................................................9
8.3 Baseline Report..................................................................................................................................9
8.3.1 Baseline Report by device family......................................................................................10
8.3.2 Baseline Report by device identification...........................................................................10
8.3.3 Baseline Report Shelf Life / Expected Life.......................................................................10
8.3.4 Baseline Reports on systems with multiple components..................................................10
8.3.5 Baseline Reports linked to 5-day reports..........................................................................10
8.3.6 Annual Baseline Update....................................................................................................10
8.3.7 Interim Baseline Update....................................................................................................10
8.4 Supplemental Report........................................................................................................................11
8.5 Annual Certification........................................................................................................................11
8.6 Where to Submit MDR Reports.......................................................................................................11
8.7 Where to Report a Public Health Emergency..................................................................................12

9.0 Medical Devices Vigilance System Reports...............................................................................................12

9.1 Types of Incidents to Report............................................................................................................12
9.2 Timescale for initial reporting of an incident or near incident.......................................................12
9.3 Where to submit incident or near incident reports..........................................................................12
9.4 Details to be included in the Initial Report.....................................................................................13
9.5 Investigation.....................................................................................................................................13
9.6 Investigation Outcome and Follow-Up Action................................................................................13
9.7 Completion of Investigation and Closure........................................................................................13

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1.0 Purpose
To establish and implement a system for reporting adverse incidents as a basis for effective
identification and evaluation of adverse events, and timely submission of Medical Device Reports to the
FDA and/or incident reports to Competent Authorities of the Medical Devices Vigilance System.

2.0 Scope
This procedure applies to reportable events of products manufactured at all facilities of [Company
Name].

1.0 Definition Of Terms

1.1 Advisory Notice

A notice issued to provide information and/or to advise on what action should be taken in the use,
modification, disposal or return of a medical device (see also Recall).

1.2 Attachments
Copies of any test reports, laboratory reports, service records and reports, records of
investigations, lab notebook notes, or any completed forms.

1.3 Becomes Aware

[Company Name] "Becomes aware" of an MDR reportable event when: (1) any employee
becomes aware of a reportable event that is required to be reported within 30 days or required to
be reported within 5 days pursuant to a written request from FDA; and (2) any employee, who is
a person with management or supervisory responsibilities over persons with regulatory, scientific,
or technical responsibilities, or a person whose duties relate to the collection and reporting of
adverse events, becomes aware that a reportable event, from any information, including any trend
analysis, necessitates remedial action to prevent an unreasonable risk of substantial harm to the
public health.

1.4 Corrective Action

Corrective action includes, but may not be confined to: device recall; issue of advisory notice;
additional surveillance/modification of devices in use; modification to future device design,
components or manufacturing process; modification to labeling or instructions for use.

1.5 Date Event Reported

The date a [Company Name] employee becomes aware of a problem / event.

1.6 Date of Problem / Event

The date a problem / event occurred which may be a reportable event.

1.7 Device Family

A "device family" is a group of one or more devices manufactured by or the same manufacturer
and having the same basic design and performance characteristics related to device safety and
effectiveness; intended use and function; and device classification and product code.

1.8 Expected Life

"Expected Life" is the time that a device is expected to remain functional after it is placed into
use.

1.9 Incident
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as
any inadequacy in the labeling or the instructions for use, which might have led to the death of a
patient or user or to a serious deterioration in his state of health. Also, any technical or medical
reason in relation to the characteristics or performance of a device leading to systematic recall of
devices of the same type by the manufacturer.

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1.10 Information Reasonably Known

Information that can be obtained by contacting a user facility, distributor and/or initial reporter,
any information in [Company Name]'s possession, or any information that can be obtained by
analysis, testing or other evaluation of the device.

1.11 Intended Purpose

The use for which the device is intended according to the data supplied by the manufacturer on
the labeling, in the instructions and/or in promotional materials.

1.12 Malfunction
A "malfunction" is a failure of the device to meet its performance specifications or otherwise
perform as intended.

1.13 Manufacturer
The natural or legal person with responsibility for the design, manufacture, packaging and
labeling of a device before it is placed on the market under his own name, regardless of whether
these operations are carried out by that person himself or on his behalf by a third party.
Also, the natural or legal person who assembles, packages, processes, fully refurbishes and/or
labels one or more ready-made products and/or assigns to them their intended purpose as a device
with a view to their being placed on the market under his own name.

1.14 Manufacturer Report Number

The "Manufacturer Report Number" is the number that identifies each individual adverse event
report submitted by a manufacturer. It consists of three parts: (1) registration number of
manufacturing site, (2) four digit calendar year the report was submitted, and (3) five digit
sequence number of the report submitted during the year.

1.15 Medical Advisor

"Medical Advisor" refers to individuals who:
(1) Are licensed, registered, or certified by a State, territory, or other governing body, to
administer health care; (2) have received a diploma or a degree in a professional or scientific
discipline; (3) are employees responsible for receiving medical complaints or adverse reports; or
(4) are supervisors of such persons.

1.16 Medical Device Report (MDR)

A report submitted to the FDA by [Company Name] in the event a device may have caused or
contributed to a death, serious injury, or has malfunctioned and that the device or a similar device
marketed by [Company Name] would likely to cause or contribute to a death or serious injury if
the malfunction were to recur.

1.17 MDR Reportable Events

"MDR reportable events are the adverse events or problems that the medical device regulation
requires to be reported. [Company Name] must report device - related deaths, serious injuries,
and device malfunctions which are likely to cause or contribute to a death or serious injury if they
were to recur.

1.18 Medical Devices Vigilance System (MDVS)

A system used to notify and evaluate adverse incidents that occurred within the Member States of
the European Community and all other States within the European Economic Area (EEA) with
regard to medical device(s), which carry the CE marking.

1.19 Near Incident

Any malfunction or deterioration in the characteristics and/or performance of a device, as well as
any inadequacy in the labeling or the instructions for use, which might lead to the death of a
patient or user or to a serious deterioration in his state of health.

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1.20 Permanent Impairment

"'Permanent impairment" means irreversible or damage to a body structure or function, excluding
trivial impairment or damage.

1.21 Product
Product that has been returned by a customer or has failed in the manufacturing process

1.22 Recall
When there is a risk of death or serious deterioration to the state of health, the return of a medical
device to the supplier, its modification by the supplier at the site of installation, its exchange or
its destruction, in accordance with the instructions contained in an advisory notice.

1.23 Remedial Action

"Remedial Action" is any action, other than routine maintenance or servicing of a device
necessary to prevent recurrence of a reportable event.

1.24 Reporter
A [Company Name] employee or Department that reports a problem / event which may be a
reportable event.

1.25 Serious Deterioration in State of Health

A life threatening illness or injury; permanent impairment of a body function or permanent
damage to a body structure, or; a condition necessitating medical or surgical intervention to
prevent permanent impairment of a body function or permanent damage to a body structure.

1.26 Serious Injury / Serious Illness

"Serious Injury / Serious Illness" is an injury or illness that: (1) is life threatening, even if
temporary in nature; (2) results in permanent impairment of a body function or permanent
damage to a body structure; or (3) necessitates medical or surgical intervention to preclude
permanent impairment of a body function or permanent damage to a body structure.

1.27 Shelf Life

"Shelf Life" is the maximum time a device will remain functional from the date of manufacture
until it is used in patient care.

1.28 Single Fault Condition

Condition in which a single means for protection against hazards is defective or a single external
abnormal hazardous condition is present.

1.29 User Error

"User Error' means any error made by the person using the device. A user error may be the sole
cause or merely contribute to a reportable event.

1.30 Work Day

"Work Day" refers to any day Monday through Friday, excluding Federal holidays.

1.31 References
Customer Servicing
Customer Complaint Processing
Field Service
Corrective and Preventive Action
Correction or Removal of Marketed Product
Quality Records
Quality Investigation
Returned Product Authorization, Evaluation, and Disposition
Quality System Report to Senior Management

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Medical Device Report Event Form

Medical Device Report Analysis Form
Vigilance System Initial Incident Report
Vigilance System Final Report
MDR/MDVS Log
MDVS Contacts
21 CFR Part 803 Medical Device Reporting
FDA Form 3500A MedWatch
FDA Form 3417 Medical Device Reporting Baseline Report
FDA Form 3381 Medical Device Reporting: Annual Certification
90/385/EEC Active Implantable Medical Devices Directive (OJ L189, 20
July 1990)
93/42/EEC Medical Devices Directive (OJ L169 of 12 July 1993)
MEDDEV 2.12/1 Guidelines on a Medical Devices Vigilance System, February
1998 - rev. 3

NOTE: It is the responsibility of the individual who downloads this template for guidance to make
sure these are the latest versions of the FDA and EEC references.

2.0 Responsibilities and Requirements

2.1 Quality Assurance Manager

Responsible for determining final disposition of reported adverse events or problems and
forwarding a MDR to the FDA or an incident report to the Competent Authorities of the Medical
Devices Vigilance System.

2.2 [Employee Title], Quality Systems

Responsible for management review status of all MDR's submitted to the FDA or incident reports
submitted to the Competent Authorities of the Medical Devices Vigilance System.

2.3 Medical Advisor

Responsible for performing investigations and overseeing a clinical assessment to recommend a
solution.

2.4 [Company Name] Employees

Responsible for reporting "reportable events" to Quality Assurance.

3.0 MDR Reportable Events

A report is required when [Company Name] becomes aware of information that reasonably suggests that
one of its marketed devices has or may have caused or contributed to a death, serious injury, or has
malfunctioned, and that the device or a similar device marketed by [Company Name] would be likely to
cause or contribute to a death or serious injury if the malfunction were to recur. In addition only one
medical device report is required if [Company Name] becomes aware of information from multiple
sources regarding the same patient and same event.

3.1 Malfunction
A malfunction should be considered reportable if any one of the following is true:

• The chance of a death or serious injury occurring as a result of a recurrence of the

malfunction is not remote;

• The consequences of the malfunction affect the device in a catastrophic manner that may
lead to a death or serious injury-, it causes the device to fail to perform its essential function
and compromises the device's therapeutic, monitoring or diagnostic effectiveness which
could cause or contribute to a death or serious injury, or other significant adverse device
experiences. The essential function of a device refers not only to the device's labeled use, but

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for any use widely prescribed within the practice of medicine; it involves an implant
malfunction that would likely to cause or contribute to death or serious injury, regardless of
how the device is used;
• The device is considered life-supporting or life-sustaining, and thus essential to maintaining
human life; or
The manufacturer takes or would be required to take action under section 518 or 519 (f) of
the Food and Drug Cosmetic Act as a result of the malfunction of the device or other similar
devices;
• A malfunction which is or can be corrected during routine service or device maintenance
must be reported if the recurrence of the malfunction is likely to cause or contribute to a
death or serious injury if it were to recur.

3.2 Caused or Contributed

If a device was or may have been attributed or a factor in a death or serious injury, it should be
considered reportable if any one of the following is true: device failure; device malfunction;
improper or inadequate device design; manufacture; labeling; or user error.

3.3 Reasonably Suggests

Any information such as professional, scientific, or medical facts and observations or opinions
that would reasonably suggest that a device has caused or contributed to a reportable event.

3.4 Concept of "may have"

A report is required when [Company Name] has information that suggests that a device has or
"may have" caused or contributed to a death or serious injury of a patient.

4.0 MDR Non-Reportable Events

The following is a list of events that are not reportable:
Malfunctions are not reportable if they are not likely to result in a death, seriousinjury or
other significant adverse event experience;
When [Company Name] determines that the information that they received is inaccurate and
a death or serious injury did not occur;
When another manufacturer made the device.

5.0 Procedure

5.1 Reporter
Upon receipt or identity of a presumable reportable problem or event as defined in the definition
of terms of this procedure, reporter fills out the MDR Event Form.

Reporter fills in date of problem or event and date problem or event reported to [Company
Name].

If the event was an internal event, reporter fills in device name, model number, serial / lot
number and details of event.

If the event was an external event generated by a customer complaint, the reporter refers to the
Customer Complaint Form.

The Reporter signs and dates and gives MDR Event Form with any attachments and product, if
any, to Quality Assurance.

5.2 Quality Assurance

Attaches Medical Device Report Analysis Form to Medical Device Report Event Form, and
records date MDR Event Form Received from Reporter.

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Assigns a sequential report number to the problem / event and enters the problem/ event into the
MDR/MDVS Log. The report number will consist of the letters "MDW' followed by the last two
digits of the year then a sequential number. The sequential number will begin with "001". Ex.
MDR97001

If product was received , verifies device name, model number, serial / lot # on MDR Event Form.

Determines if additional information is needed to make a determination if the problem / event is

reportable or non-reportable.

If additional information is needed, requests additional information through a written letter, fax
or phone requests to the reporter and records date requested and attaches any attachments or
documents phone conversation details.

If additional information is not needed, documents reasons why on the Medical Device Report
Analysis Form.

If an investigation is necessary, initiates investigation and attaches results of the investigation to

the Medical Device Report Analysis Form. Reference (Quality Investigation)

Makes I copy of the MDR Event Form and MDR Analysis Form and attachments, and distributes
the copy to the "MDR Event Under Investigation" folder.

Determines if the event is reportable or not according to additional information obtained or

investigation results if necessary.

Documents the reason why or why not the event was reportable.

If the event was reportable, submits appropriate Medical Device Report to the FDA and
documents date submitted and by whom.

Makes 2 copies of the MDR Event Form, MDR Analysis Form, and Quality Investigation Form
and attachments, and distributes one copy to the "MDR Event Closed" folder and attaches one
copy to the customer complaint form if applicable and removes the previously filed MDR Event
form from the "MDR Event Under Investigation" folder.

6.0 Types of MDR Reports

There are five types of NOR reports that FDA requires [Company Name] to submit. All written MDR
reports will be in the English language. These reports include:

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Table 8.0

Report Type: REPORT WHAT? VVMN?

30- day report 30-day reports of deaths, serious Within 30 calendar days from
injuries and malfunctions becoming aware of an event.
5-day report 5-day reports on events that Within 5 work days from
require remedial action to becoming aware of an event.
prevent an unreasonable risk
of substantial harm to the public
health and other types
of events designated by FDA.
Baseline report Baseline report to identify and Within 30 calendar and 5 work
provide basic data on each days when device or device
device that is subject of an MDR family is reported for the first
Report. time.
Supplemental report This report will contain Within one month (30 calendar
information that was unknown, days) following receipt of
not available, or new facts that additional information on FDA
alter any information on the form 3500A.
original 30-day or 5-day MDR
reports.

Annual certification Annual updates are also Coincides with Company’s

required annual registration dates.
if any baseline information
changes after initial submission.
Annual Certification -may not
be required - see section 9.5

6.1 30-Day Report

[Company Name] will submit an individual adverse event (MDR) report to the FDA, on form
FDA 3500A within 30 calendar days after becoming aware of a reportable death, serious injury,
or malfunction.

6.2 5-Day Report

[Company Name] will submit a 5-day report to the FDA on form FDA 3500A within five work
days after: (1) becoming aware that a reportable event necessitates remedial action to prevent an
unreasonable risk of substantial harm to the public health; or (2) becoming aware of an MDR
reportable event from which the FDA has made a written request for the submission of a 5-day
report involving a particular type of medical device or type of event.

NOTE. The 5-day time frame for remedial actions begins the day after any employee, who is a
person with management or supervisory responsibilities over persons with regulatory, scientific,
or technical responsibilities, or a person whose duties relate to the collection and reporting of
adverse events, "becomes aware" that a reportable MDR event has occurred. The 5-day time
frame for reports requested by FDA begins when any employee of [Company Name] becomes
aware that a reportable event has occurred.

6.3 Baseline Report

[Company Name] will submit a baseline report (accompanying the corresponding Form 3500A)
when an event involving the device model or device family is reported for the first time.
[Company Name] will submit a baseline report to the FDA using form 3417, which provides
basic device identification information. The report will be submitted by either model type (one
baseline report for each model) or by device family (one baseline report for all models in that
family).

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6.3.1 Baseline Report by device family

A list of all models in the family must be attached to the baseline report.

6.3.2 Baseline Report by device identification

On form 3417 this includes brand name, device family designation, model
catalog # and any other device identification number.

6.3.3 Baseline Report Shelf Life / Expected Life

If there is no shelf life or expected life of the device (N/A) shall be checked on Form
3417.

6.3.4 Baseline Reports on systems with multiple components

If the device consists of several different stand alone medical device components, and
one component is involved in a reportable event, FDA may require a baseline report. If
the component is a finished device, bearing its own unique device identifier, then a
baseline report is submitted for the component if the suspect device was the component.
If the system has a device identifier and identifying the unique component is not
possible, then file a baseline report on the entire system. This policy does not apply to
kits of assembled devices.

6.3.5 Baseline Reports linked to 5-day reports

If a device, which is the subject of a 5-day report, is being reported for the first time,
[Company Name] will submit Form 3417 baseline report to the FDA. If all information
cannot be obtained [Company Name] will explain in a cover letter to the FDA an
expected date of submission of the remaining information.

6.3.6 Annual Baseline Update

The annual update report shall be submitted at the same time of [Company Name]'s
annual registration by using FDA form 3417 occurring during the twelve - month
period. Annual baseline updates should cover the time period from the initial baseline
report or last annual update, whichever is later, to the present annual registration filing.
If the annual registration is due less than six months after the initial baseline report is
submitted, then the annual baseline report would not be required until the next annual
registration is due. Changes requiring an annual baseline update include; (1) the
addition of models to a device family or (2) changes in information in blocks 1- 14 on
FDA form 3417.

An annual update to a baseline report does not have to be submitted if during the
previous twelve month period, there were no I~MR reportable adverse events filed with
the FDA for the current model(s) or for any new model(s) that may have been added to
the initial baseline report during that designated time period and there were no other
changes in the information previously submitted. This waiver remains in effect until
[Company Name] files an adverse event report either for the current model(s), or
[Company Name] adds new models after the last update. In this case, an annual update
report is required at the time of the next annual registration and will contain the same
information identified above. The update must include the designated information
covering the time frame from the last baseline report update to the present. This may be
a period longer than 12 months.

6.3.7 Interim Baseline Update

[Company Name] will submit a baseline update report when a new model(s) is added to
the device family. However, if, prior to submission of the annual update, a new model(s)
subsequently becomes the subject of an MDR reportable adverse event, then an interim
report is required, to report the new model involved in the event.

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6.4 Supplemental Report

[Company Name] will submit a supplemental report within one month (30 calendar days)
following receipt of additional information on FDA form 3500A. This report will contain
information that was unknown, not available, or new facts that alter any information on the
original 30-day or 5-day MDR reports.

6.5 Annual Certification

Under the FDA Modernization Act of 1997 (FDAMA), which became effective February 19,
1998, manufacturers are no longer required to submit an annual certification statement.
Therefore, [Company Name] will not submit an annual MDR certification. Reference to the
annual certification will remain in this SOP until the FDA deletes annual certification from 21
CFR 803, Medical Device Reporting.

6.6 Where to Submit MDR Reports

To ensure the proper processing of all reports, the outside of the envelope shall be labeled in a
specific manner. FDA will accept more than one type of report per envelope. If multiple types of
reports are enclosed, the envelope should be labeled indicating each type of report enclosed. The
mailing and labeling requirements are noted in table 8.6.

Table 8.6.
TYPE OF MDR REPORT Code level IDENTIFICATION OF
FORM ENVELOPE: Place in lower
left-hand corner of the
envelope above bar.
5-Day 3500A 5-Day Report
30-Day 3500A 30-Day Manufacturer Report
Supplemental 3500A Manufacturer Supplemental
Report
Baseline 3417 Baseline Report or Annual /
Interim Update Baseline Report

Annual Certification - not 3381 Manufacturer Annual

Required - see section 8.5, Certification Report
Annual
Certification

All MDR Reports should be sent to:

Food and Drug Administration

Center for Devices and Radiological Health
Medical Device Reporting
P.O. Box 3002
Rockville, MD 20847-3002
All MDR Reports may be faxed to FDA with prior approval by calling:

(301)594-3886

6.7 Where to Report a Public Health Emergency

If there is a public health emergency, a telephone report should be followed by a facsimile report.

FDA Emergency Operations Branch

Office of Regional Operations, HFC -162 Phone: 301-443-1240 Fax: 301-443-3757

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7.0 Medical Devices Vigilance System Reports

The Medical Devices Vigilance System (MDVS) is a system for the notification and evaluation of
adverse incidents concerning any medical device that carries the CE marking. The MDVS implements
the requirements of Article 8 of the Active Implantable Medical Devices Directive (90/385/EEC), and
Article 10 of the Medical Devices Directive (93/42/EEC). Guidance on the MDVS is contained in
Guidelines on a Medical Devices Vigilance System.

7.1 Types of Incidents to Report

Any incident involving a CE marked medical device occurring within the European Economic
Area (EEA) should be evaluated for reporting under MDVS. If the incident led to death, a serious
deterioration in the state of health, or could have led to a serious deterioration in the state of
health (near incident) of the patient, user, or other person, then the incident should be reported
under MDVS, providing the device caused or contributed to the incident.

When assessing the link between the device and the incident or near incident, the opinion of
health care professionals, the preliminary assessment of the incident, knowledge of previous
similar incidents, and other knowledge of the device should be taken into account. The following
may indicate an association between the device and the incident:

Malfunction or deterioration in the characteristics and/or performance of the device

• A device with a characteristic which could lead to an incident, even though the device has
not malfunctioned or deteriorated (report as a near incident)

• Inaccuracies, omissions or deficiencies in the device labeling

For additional clarification on the types of incidents or near incidents to report, see the
Guidelines On A Medical Devices Vigilance System.

7.2 Timescale for initial reporting of an incident or near incident

An initial report should be filed as soon as possible, but no later than 10 days for incidents, and
30 days for near incidents. The time period runs from [Company Name] first being informed of
the incident or near incident, to the relevant Competent Authority receiving the initial report.

If [Company Name] determines within 10 days for an incident or within 30 days for a near
incident that the device was not the cause of the incident or near incident, then an initial report is
not filed, and this procedure terminates.

For incidents occurring outside the EEA which lead to corrective action on CE marked devices
within the EEA, an initial report should be filed as soon as possible, once the decision is made to
perform corrective action on CE marked devices within the EEA.

7.3 Where to submit incident or near incident reports

The initial report should be submitted to the Competent Authority in the country in which the
incident occurred. If an incident involving an implantable device occurred in a Member State
other than the Member State in which the device was implanted, then the Member State in which
the device was implanted should also be notified, if known.

For incidents occurring outside the EEA which lead to corrective action on CE marked devices
within the EEA, the initial report should be made, for Class Il or Class III devices, to the
Competent Authority in the country where the Notified Body is located which attested to the CE
marking for the device, or for Class I devices, to the Competent Authority in the country in which
Authorized Representative for the device is located.

For the list of Competent Authorities, as well as the Authorized Representative, Notified Body,
and Distributors for [Company Name] CE marked product, see MDVS Contacts.

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In addition to filing an initial report with the appropriate Competent Authority, consideration
should be given to notifying the Authorized Representative, the Notified Body attesting to the CE
mark, and distributors of the device.

7.4 Details to be included in the Initial Report

Use the Vigilance System Initial Incident Report form for filing the initial report with the
appropriate Competent Authority. Complete all applicable sections of the form, and attach sheets
if necessary to include all relevant information. The name, address, contact person, and
telephone/fax number of the Authorized Representative should be included in the report.

Retain a copy of the report and enter the report into the MDR/MDVS Log. If the report is first
made by telephone or fax, written confirmation should be mailed as soon as possible. When
acknowledgment of receipt by the Competent Authority is received, attach acknowledgment to
the initial report copy.

7.5 Investigation
Investigate the incident or near incident, keeping the Competent Authority informed as necessary
and cooperating with the Competent Authority as requested. If a single coordinating Competent
Authority is named, then all correspondence should be with the coordinating Competent
Authority, unless otherwise instructed. If [Company Name] cannot investigate an incident, then
we must inform the Competent Authority immediately.

Carry out the investigation in an organized and timely manner. Gather information from the
individuals involved in the incident. Examine the device involved in the incident, if possible
(note: any examination of the device which alters the condition of the device requires prior
notification of the Competent Authority). Determine the root cause of the incident and
appropriate actions to be taken, if any. Obtain information from and coordinate information with
other [Company Name] systems during the investigation, such as Customer Complaint
Processing, Field Service, Customer Servicing, Corrective and Preventive Action, Correction or
Removal of Marketed Product, Quality Investigation, and Returned Product Authorization,
Evaluation, and Disposition.

7.6 Investigation Outcome and Follow-Up Action

The investigation outcome and follow-up action may include: no action; additional surveillance
or follow-up of devices in use; dissemination of information to users by advisory notice;
corrective action on future production; corrective action on devices in use, or; recall. Any
corrective action or recall of products in use must be performed according to Correction or
Removal of Marketed Product, QA020-SP.

7.7 Completion of Investigation and Closure

When [Company Name]'s investigation is complete and follow-up action has been determined, a
Final Report must be filed with the appropriate Competent Authority. Use the Vigilance System
Final Report form (#_VSFR) for filing the final report.

Complete all applicable sections of the form, and attach sheets if necessary to include all relevant
information.

The final report should be sent to all Competent Authorities who received an initial report from
[Company Name]. Consideration should also be given to sending the final report to the
Authorized Representative, the Notified Body attesting to the CE mark, and distributors of the
device.

The Competent Authority will inform [Company Name] when the file is endorsed as "closed".
[Company Name] will also be informed of the results of investigations by Competent Authorities,
if any.

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All records associated with the incident or near incident shall be maintained as Quality Records.
Be sure to update the MDR/MDVS Log when a file is closed.

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