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Guidelines on a Medical Devices Vigilance System
1. Introduction
1.1.1 These Guidelines describe a system for the notification and evaluation of
adverse incidents to be known as the Medical Devices Vigilance system. They are intended
to facilitate the uniform application and implementation of the Directive for Active
Implantable Medical Devices (AIMD) and the Directive for Medical Devices (MDD). In
particular, Article 8 (AIMD) and Article 10 (MDD) outline the obligations of Member States
upon receipt of incident reports, from manufacturers or other sources, concerning any
medical device which carries the CE marking.
These Guidelines also give guidance on those Annexes of the Directives which oblige the
manufacturer to report certain types of incident to Competent Authorities.
These Guidelines are not enforceable by law.
Relevant extracts from both Directives are provided in Appendix 7.
A diagrammatic summary of the system is given in Appendix 9.
1.1.2 These Guidelines cover the activities of
- the Commission, Competent Authorities,
- Notified Bodies,
manufacturers (including their authorised representatives and persons responsible for
placing on the market, see Article 14 of the MDD), users and others concerned with the
continuing safety of medical devices.
For the purposes of Medical Devices Vigilance, Member States are represented by the
Competent Authorities listed in Appendix 1.
1.1.3 These Guidelines cover the action to be taken once the manufacturer or Competent
Authority receives information concerning an incident. Information on incidents which
should be reported under the Vigilance system may come to the attention of manufacturers
via the systematic procedure to review experience gained from devices in the
post-production phase, or by other means (see Annexes 2, 4, 5, 6, 7 of MDD). The term
"post-marketing surveillance" as referred to in Annex 2, 4, 5 in AIMD has the
same meaning as the aforementioned "systematic procedure..
These Guidelines make no recommendations on the structure of the systems by which
manufacturers gather information concerning the use of devices in the post-production
phase.
1.1.4 This medical devices vigilance system takes precedence over information systems
to be installed under the requirements of the Council Directive 92/59/EEC of 29/6/1992 on
General Product Safety1
1. 2 User and other incident
reporting systems
1.2.1 Member States may wish to supplement reports received from manufacturers
under the Vigilance system with reporting from other sources. Member States should adopt
administrative measures to ensure that the pertinent manufacturers are informed without
delay of reports meeting the criteria set out later in these Guidelines (see para 6.4).
1.2.2 In order to enhance the efficacy of the Medical Device Vigilance system,
Competent Authorities should encourage the reporting of adverse events by the user. Such
reports may be made either directly to the Competent Authority, or to the manufacturer, or
to both depending on National practice.
1. 3 Applicability
1.3.1 These Guidelines refer to incidents occurring within the Member States of the
European Community and all other States within the European Economic Area (EEA) with
regard to:
- devices which carry the CE-mark
and
- devices which do not carry the CE-mark, where such incidents lead to corrective action
relevant to CE-marked devices.
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 labelling or
instructions for use.
These Guidelines do not apply to devices under clinical evaluation or investigation -
see Annex 7 of AIMD and Annex 10 of MDD.
1.3.2 If incidents which occur outside the EEA lead to corrective action
relevant to CE-marked devices which are offered for sale or are in use within the EEA,
then manufacturers should notify the relevant Competent Authorities.
1.3.3 These Guidelines are intended to be applicable equally to the
Directive for Active Implantable Medical Devices and the Medical Devices Directive. The
procedures are intended to be the same for both Directives, with respect to the Vigilance
system.
2 For whom these
guidelines are written
2.1 Manufacturers
These Guidelines apply to manufacturers placing medical devices on the market in
accordance with the AIMD and the MDD. The definition of the term manufacturer" is
given in Appendix 2.
2.1.2 Manufacturers should ensure that these Guidelines are made known to their
authorised representatives within the EEA, persons responsible for placing devices on the
market and any other agents authorised to act on their behalf for purposes related to
Medical Devices Vigilance, so that the manufacturers' responsibilities may be fulfilled.
2.2 Competent authorities
These Guidelines cover Competent Authorities' responsibilities, in particular under
Article 2 of AIMD and MDD, and article 8 of AIMD and Article 10 of MDD.
2.3 Notified Bodies
Notified Bodies may be consulted by Competent Authorities or manufacturers following
incidents involving, for example, medical devices for which they have provided
attestations leading to a CE mark.
2.4 Health-care Organisations and Personnel
Member States should ensure that organisations and individuals involved in purchasing
medical devices and in the provision of health-care are aware that their co-operation is
vital in providing the first link in the Vigilance chain. This includes organisations and
individuals responsible for providing calibration and maintenance for medical devices.
3 Purpose of the
Vigilance System
3.1.1 The purpose of the Vigilance system is to improve the protection of
health and safety of patients, users and others by reducing the likelihood of the same
type of adverse incident being repeated in different places at different times. This is to
be achieved by the evaluation of reported incidents and, where appropriate, dissemination
of information which could be used to prevent such repetitions, or to alleviate the
consequences of such incidents.
3.1.2 The Vigilance system is intended to allow data to
be correlated between Competent Authorities and manufacturers and so facilitate corrective
action earlier than would be the case if data were collected and action taken on a State
by State basis.
3.1.3 Whilst the manufacturer has the responsibility for taking any action necessary,
Competent Authorities should also monitor the effectiveness of the manufacturers follow-up
on reported incidents. The Competent Authority should take any further action that may be
necessary to supplement the actions of the manufacturer.
3.1.4 Once corrective (or other) action is identified, hospital administrators, medical
practitioners and other health-care professionals and user representatives responsible for
the maintenance and the safety of medical devices, can take the necessary steps. Such
steps should, where practicable, be taken in cooperation with the manufacturer.
3.1.5 Competent Authorities may also monitor experience with devices of the same kind
(for instance, all defibrillators or all syringes), but made by different manufacturers.
They may then be able to take measures applicable to all devices of that kind. This could
include, for example, initiating user education or suggesting re-classification.
4. General Principles
4.1.1 Information held by Competent Authorities in connection with the Vigilance System
is to be held in confidence, as defined by the relevant Articles of the Directives (AIMD
15 and MDD 20). In order to achieve the purpose of the Vigilance system, any incident
report should be available on request, and in confidence, to the other Competent
Authorities (see paragraph 7.2).
4.1.2 The act of reporting an incident to a Competent Authority is not to be construed
as an admission of liability for the incident and its consequences. Written reports may
carry a disclaimer to this effect. (see paragraph 6.2)
4.1.3 The initial report on an incident under the Vigilance system is made by the
manufacturer to the Competent Authority for recording and evaluation (see paragraph 6).
Each initial report should lead to a final report (see paragraph 8.6), but not every
initial report will lead to a corrective action.
4.1.4 The manufacturer should ensure that their authorised representative within the
EEA, persons responsible for placing devices on the market and any other agents authorised
to act on their behalf for purposes relating to Medical Devices Vigilance, are kept
informed of incident reports as appropriate
The manufacturer should consider informing official distributors etc as appropriate
during the procedure. This does not affect the right of the manufacturer to determine the
person authorised to be the principle contact point for purposes of relating to Medical
Devices Vigilance.
4.1.5 It is recommended that manufacturers inform their
Notified Body of those incidents which may affect the certification provided by that
Notified Body. However, it remains the role of the Competent Authority to monitor the
investigation being carried out by the manufacturer.
4.1.6 Depending on the outcome to the investigation, any
information necessary for the prevention of further incidents (or the limitation of their
consequences) should be disseminated (see paragraph 8.4 and 8.5).
Extracts from the Annexes of the AIMD and of the MDD which define what should be
reported by the manufacturer to Competent Authorities are given in Appendix 7. Although
the wording of these Annexes to the two Directives is different, the interpretation given
in these Guidelines is nevertheless the same.
For example, the Directive for Medical Devices includes the word "serious" as
a qualification of "deterioration in his state of health". In these Guidelines,
the Directive for AIMDs is interpreted as though the word "serious" were
present.
5.2 Decision process on what a manufacturer should report
The manufacturer should assess the following points when deciding whether an incident
should be reported to a Competent Authority:
- the type of incident (or potential incident) - paragraph 5.4;
- whether any medical device may have been involved which was made by that manufacturer or
under his authority;
- whether the incident was caused (wholly or partly), or could have been caused, by the
device or by shortcomings in the information supplied with the device paragraph 5.5.
The same considerations apply to a Competent Authority's decision whether to inform a
manufacturer of an incident reported via a User Reporting or other system -see paragraph
6.4.
5.3 Access to the device suspected to be involved in the incident
A manufacturer may consult with the user on a particular incident before a report has
been made to the Competent Authority (see paragraph 6.1). The manufacturer may also wish
to have access to the device said to be involved in the incident for the purpose of
deciding whether the incident should be reported to the Competent Authority. Such access
may be affected by the requirements of National Law, and may also be at the discretion of
the user or health-care facility concerned.
If the manufacturer gains access to the device, and his initial assessment (or cleaning
or decontamination process) will involve altering the device in a way which may affect
subsequent analysis, then the manufacturer should inform the Competent Authority before
proceeding. The Competent Authority may then consider whether to intervene.
5.4 Guidelines on types of incidents to be reported
The following paragraphs describe the types of incidents which a
manufacturer should report to the Competent Authority. This is illustrated by the
simplified flow chart and the examples of such incidents, given in Appendices 4 and 5.
In assessing the type of incident, the manufacturer should consult with the medical
practitic)ner involved or other health-care professional wherever practicable.
Incidents which need to be reported are defined in the Directives as follows:
5.4.1 Those which led to a death;
5.4.2 Those which led to a serious
deterioration in the state of health of a patient, user or other person. A serious
deterioration in state of health can include:
- life-threatening illness or injury;
- permanent impairment of a body function or permanent damage to a body structure:
- a condition necessitating medical or surgical intervention to prevent permanent
impairment of a body function or permanent damage to a body structure.
Note: The interpretation of the term serious is not easy, and
should be made in consultations with a medical practitioner wherever possible. Many points
may need consideration, for example:
- whether a risk was foreseeable and clinically acceptable in view of potential patient
benefit;
- whether the outcome was adversely affected by a pre -existing condition of the patient.
In cases of doubt on this issue. it is suggested that there should be a pre
-disposition to report rather than not to report.
5.4.3 Those which might have led to death or serious deterioration in health
Not all incidents which should be reported involve a death or serious deterioration in
health 'nh~ch actually occurred. The non-occurrence of such a result might have been due
to other fortunate circumstances or to the intervention of health-care personnel.
It is sufficient that: y
- an incident associated with a device happened, and
- the incident was such that, if it occurred again, it might lead to death or serious
deterioration in health.
OR
- an examination of the device or the information supplied with the device indicated some.
Factor (eg a deterioration in characteristics or performance, or a shortcorning in the
information) which could lead to an incident involving death or serious deterioration in
health; For the purposes o! these Guidelines, such potential incidents are to be known as
"near incidents".
For a near incident to be reported, a possible direct link with the device, or with
shortcoming in the information supplied, should be clearl established.
5.5 The incident or near incident and the device or the information
supplied with the device
The following paragraphs describe the characteristics of the device, or of the
information supplied with the device, which may be associated with an incident which
should be reported.
In assessing the link between the device and the incident or near incident, the
manufacturer should take account of:
- the opinion, based on available evidence, of health-care professionals;
- the results of the manufacturer's own preliminary assessment of the incident;
- evidence of previous, similar incidents;
- other evidence held by the manufacturer.
5.5.1 Malfunction or deterioration in the characteristics and/or performance of a
device.
A malfunction is a failure of a device to perform in accordance with its intended
purpose (see Appendix 2) when used in accordance with the manufacturer's instructions.
This includes single fault conditions (e.g. component failures) which cause, or could
cause, an injury. (The EN 60601-1 definition of single fault is reproduced in Appendix 2
Definitions).
It does not include single fault conditions for which the manufacturer has made
provision (in accordance with relevant standards) and which do not cause an injury, or
potential injury. Deterioration of the device also includes problems caused by unpredicted
biological effects related to the device.
Deterioration does not include the normally expected ageing of implant materials or
depletion of batteries which were predicted in the information supplied with the device.
5.5.2 A device which shows no malfunction or deterioration, but
nevertheless has a characteristic which could lead to an incident should be reported as a
near incident.
5.5.3 Inaccuracies in the instruction leaflet, or instructions for use
include omissions and deficiencies.
The terms "instruction leaflet" and "instructions for use" include
all information provided on or with the device, such as instruction materials, or user and
maintenance manuals.
An example of an omission is a failure to warn of a side effect which may be produced
by the device
working within specification; an example of a deficiency is a lack of clarity which
leads, or could lead to, an injury.
Omissions do not include the absence of information which should generally be known by
the intended user.
Any inaccuracy in the instructions which caused, or could cause, misuse or incorrect
maintenance or adjustment should be reported.
5.5.4 Reference to the above considerations may be made in the
report, or should be kept on file by the manufacturer in the case a decision not to
report.
5.6. Timescale for the initial reporting of an incident or near
incident
The report should be made as soon as possible commensurate with determining whether the
incident falls within the guidance discussed above. The times given below are the maximum
elapsed times for determining the relevant facts and making an initial report.
The time runs from the manufacturer first being informed of the incident, to the
relevant Competent Authority receiving the notification from the manufacturer.
Incidents 10 days
Near incidents 30 days
5.7 Systematic Recalls
5.7.1 The Directives require any technical or medical
reason for the systematic recall of a device to be notified by the manufacturer to a
Competent Authority. The Term "withdrawal" used in the AIMD is interpreted in
the same way.
The term "recall" is defined in EN46001 (see Appendix).
Removals from the market for purely commercial reasons are not included.
A simplified flow chart illustrating the types of recalls to be reported is given at
Appendix 6.
5.7.2 The manufacturer should issue advisory notices when implementing
recalls. Copies of advisory notices should be sent to the Competent Authorities of the
countries to which they are applicable, and for devices in Class II or Class Ill, the
Competent Authority in the State where the Notified Body is situated and which made the
attestation which led to the CE marking being attached to the device. Manufacturers should
consider sending copies of Advisory Notices to Competent Authorities under cover of a
report which takes the same structure as the Final Report (see para 8.1.3). Notification
to Competent Authorities should be made before or at the same time as the notices are sent
to the relevant users. The terms "advisory notice" and "Recall" are
defined in EN46001 (see Appendix 2).
6 Making and
receiving an initial report between manufacturer and competent authority
6.1 Competent authority to which an initial report
should be made
6.1.1 In general, the report should be to the Competent Authority in the country of
occurrence of the incident, with the following provisos or exceptions
i) In the case of an incident involving an implant which occurs in a Member State other
than the Member State where the implant was performed, the above principle still applies.
In addition, the manufacturer should copy the report to the Competent Authority of the
State where the implant was performed, if known.
ii) Reports on incidents concerning devices in Class II or Class Ill
occurring in countries outside the EEA and which result in corrective action, should be
made to the Competent Authority in the State where the Notified Body is situated and which
made the attestations which led to the CE marking being attached to the device.
iii)Reports on incidents concerning Class I devices which occur
outside the EEA and which result in corrective action, should be made to the Competent
Authority of the Member State in which the manufacturer, or the person responsible for
placing on the market, has made his notification within Article 14 of MDD.
The list of Competent Authorities is in Appendix 1. The list is correct at the time of
writing, but there may have been changes. additions or deletions since.
6.1.2 Where appropriate, manufacturers
should notify their authorised representative, persons responsible for placing on the
market and any other agents authorised to act on their behalf of incidents reported under
the Vigilance System.
Manufacturers should inform their Notified Body of those incidents
reported under the Vigilance System which relate to the conformity assessment as carried
out be the Notified Body.
6.2 Details to be included in initial report
A recommended format for the initial report by the manufacturer to the
Competent Authority is given in Appendix 3.
6.2.1 The report should include the following details as
appropriate:
- manufacturer's name (and the name of the authorised representative within the EEA, where
relevant), address, contact point, telephone number, Fax.
- the date when the incident came to the knowledge of the manufacturer;
- -medical device kind, commercial name, catalogue number model, serial/batch/lot number,
software version;
- identification number of the Notified Body involved in the conformity assessment
procedure (if any), and the date(s) of the attestation(s);
- associated devices and/or accessories involved in the incident (if known);
- details of the incident (to the extent known) including date and patient or user outcome
-current location of device involved in the incident, if known;
- contact point of user where incident occurred (the patient's full identity should not be
- reported).(The contact point need not necessarily be the person who actually witnessed
the incident. It is recommended that health-care facilities have a contact person for all
incidents reported).
- -manufacturer's preliminary comments;
- manufacturer's proposed next action, and timescale
- a statement of whether the manufacturer is aware of similar incidents having an impact
on the current report
- if yes, the names of any other Competent Authorities to which these incidents have been
reported, and the reference date of the report (s);
- -any other EEA State in which the device is known to be on sale.
6.2.2 If the manufacturer is located outside the EEA, a suitable contact
point within the EEA should be provided. This may be the manufacturer's authorised
representative, persons responsible for placing devices on the market or any other agent
suthorised to act on their behalf for purposes relating to Medical Devices Vigilance.
6.2.3 The report should not be unduly delayed because of incomplete information.
If the initial report is made by means other than by letter post (eg
telephone, fax), it should be followed as soon as possible by a written confirmation.
6.2.4 The report may also include a statement to the effect that the report is made by
the manufacturer without prejudice and does not imply any admission of liability for the
incident or its consequences.
6.3 Competent authority actions on receipt of an initial
report from a manufacturer
6.3.1 The Competent Authority should acknowledge the receipt of the report to the
sender.
6.3.2 The Competent Authority should record the report - this should involve
categorising the incident, for example:
- by date (of incident, receipt by manufacturer, receipt by Competent Authority);
- by outcome (death, injury or near incident); by manufacturer and model;
- by device kind, using appropriate nomenclature;
- by "coordinating" Competent Authority for this type of incident (if any - see
paragraph 7.2);
- by the date when the manufacturer's next action is due.
6.3.3 The Competent Authority should evaluate the report and intervene as appropriate,
in consultation with the manufacturer if practicable (see para 7).
6.4 Competent authority actions on reports from user or other
systems
6.4.1 A report which appears to meet the criteria of para 5, received by a
Competent Authority from a User Reporting system or other source, should be copied by the
Competent Authority to the manufacturer without delay. In doing so, patient
confidentiality should be maintained.
6.4.2 Once the manufacturer has been so informed, the subsequent procedure is the same,
as far as practicable, as that described in Section 7 onwards of these Guidelines.
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