|
Guidelines on a Medical Devices Vigilance
System 7. PROCEDURE
FOLLOWING THE INITIAL REPORT
7.1 PRINCIPLES
7.1.1 The manufacturer normally performs the investigation, while the Competent
Authority monitors progress. The Competent Authority may intervene, or initiate
independent investigation if appropriate. This should be in consultation with the
manufacturer where practicable. (See paragraph 7.4).
7.1.2 In the case of incidents of, groups of incidents, or recalls involving more than
one Competent Authority, there may emerge a single coordinating Competent Authority. Most
communications should then be between the "coordinating" Competent Authority and
the manufacturer. (See paragraph 7.2).
7.1.3 It is possible that the action concerning an incident may be completed without
further investigation following the initial report.
Note: The above principles are generalised and do not take account of interventions by
judicial or other agencies.
7.2 CO-ORDINATION BETWEEN COMPETENT AUTHORITIES
7.2.1 Initial reports are not normally disseminated between Competent Authorities.
In the case of initial reports which confirm that incidents meet the criteria set out in
paragraph 8.4.1, information should be disseminated between Competent Authorities and to
the Commission at this stage (see paragraph 8.4). In the unusual event that an inital
report is to be disseminated, the Competent Authority should inform the manufacturer prior
to issue.
However, in order to achieve the purpose of the Vigilance system, any report made by a
manufacturer to an individual Competent Authority should be accessible in confidence to
the other Competent Authorities on request.
7.2.2 Competent Authorities should determine a single coordinating Competent Authority
under the following circumstances:
- incidents of similar types occurring in more than one country within the EEA, and which
lead to corrective action;
- recalls conducted in more than one country within the EEA, whether or not a reportable
incident has occurred.
The following hierarchy should determine the coordinating Competent Authority, unless
otherwise agreed between Competent Authorities:
- the Competent Authority which received the first initial report concerning this type of
incident.
- the Competent Authority in the State where the manufacturer or his authorised
representative is situated.
- the Competent Authority in the Stare where the Notified Body which made the attestation
leading to CE-marking, is situated;
7.2.3 The coordinating Competent Authority has responsibility for:
- monitoring the investigation and coordinating contacts with the manufacturer on behalf
of other Competent Authorities;
- accessing the expertise of the relevant Notified Body and coordinating with other
Competent Authorities within the EEA;
- discussing with the manufacturer the principles, need and circumstances of corrective
actions to be taken within the EEA;
- disseminating details of incidents which meet the criteria set out in paragraph 8.4.1 to
other Competent Authorities and the Commission, including confirming the names of other
States affected by recalls etc.
- receiving and pooling data and experience from other Competent Authorities;
7.2.4 Confirmation of a co-ordinating Competent Authority where applicable should be
provided on the Competent Authority Report (see paragraph 8.4.2) under "reason for
report" (see Appendix 8.).
7.2.5 Such an arrangement would not affect the rights of an individual Competent
Authority to perform its own monitoring or investigation, or to instigate action within
its Member State in accordance with the provisions of the relevant Directives.
7.2.6 COMMITTEE ON MEDICAL DEVICES
If similar reports are being investigated in different Member States, it is recommended
that the Commission should be informed, so that it can facilitate or support measures such
as those described above. At the initiative of the Commission or the Member State, the
matter may be discussed in the framework of the Committee on Medical Devices.
7.3 MANUFACTURER ROLE FOLLOWING THE INITIAL REPORT
7.3.1 The manufacturer normally performs the investigation following the
initial report, keeping the Competent Authority informed of progress as appropriate.
7.3.2 If the manufacturer is not able to perform the investigation of an incident then
he should inform the Competent Authority without delay.
7.4 COMPETENT AUTHORITY ROLE FOLLOWING THE INITIAL REPORT
7.4.1 The Competent Authority normally monitors the investigation being carried out
by the manufacturer. However, the Competent Authority may intervene at any time. Such
intervention should be in consultation with the manufacturer where practicable.
7.4.2 Aspects of the manufacturer's investigation which may be monitored include, for
example:-course, or direction the investigation is taking;
conduct, or how the investigation is being carried out; progress, or how quickly the
investigation is being carried out; outcome, or whether the results are satisfactory.
7.4.3 Facts which may be needed include, for example:
- the number of devices involved;
- the length of time they have been on the market;
- details of design changes which have been made.
7.4.4 Liaison may be needed with:
- Notified Bodies (involved in the attestation leading to the CZ- marking); users;
- other Competent Authorities;
- other independent bodies, test houses etc.
7.4.5 The Competent Authority should consider liaison with other (non-medical device)
Competent Authorities, for example if a medicinal product is involved.
7.4.6 The Competent Authority should take coordinating action to ensure an
investigation is carried out if several manufacturers are involved.
7.4.7 If the manufacturer cannot for any reason perform the investigation, then the
Competent Authority should ensure an investigation is carried out. The manufacturer should
be kept informed.
7.4.8 Competent Authorities may also monitor experience with the use of 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
8 OUTCOME
OF AN
INVESTIGATION, AND FOLLOW-UP
8.1 PRINCIPLES
8.1.1 Normally, the manufacturer should take the action necessary
following the investigation, including consultation with the Competent Authority and
performing any recalls - see paragraph 8.2.
8.1.2 The Competent Authority may take any further action it deems appropriate,
consulting with the manufacturer where possible - see paragraph 8.3.
8.1.3 There should be a final report which is a written statement of the outcome of the
investigation and of any action. This is made by the manufacturer to the Competent
Authority. If the Competent Authority performs the investigation then the manufacturer
should be informed of the result - see paragraphs 8.2, 8.3 and 8.6.
8.2 MANUFACTURER ACTIONS
8.2.1 The manufacturer should make a final report to the relevant
Competent Authority - see also paragraphs 8.3 and 8.6.
A suggested format for the manufacturer's final report is in Appendix 3.
8.2.2 Outcomes may include, for example:
- no action;
- additional surveillance or follow-up of devices in use;
- dissemination of information to users, eg by advisory notice; corrective action on
future production;
- corrective action on devices in use;
- recall.
8.3 COMPETENT AUTHORITY ACTIONS
8.3.1 The Competent Authority should receive the final report from the manufacturer
concluding the investigation -see paragraph 8.6.
8.3.2 Competent Authority actions should be in consultation with the manufacturer
wherever practicab
8.3. 3 le.The Competent Authority should consider the content and method of
dissemination of any advisory note, in consultation with the manufacturer and medical
practitioner if appropriate - see paragraph a.s
8.3.4 Other Competent Authority actions may include, for example:
- no action;
- gathering more information, for example by commissioning independent reports;
- making recommendations to manufacturers, for example to improve information provided
with the device;
- keeping the Commission and other Competent Authorities informed, for example on recalls
and other actions to be taken; the information may be in the format of a Competent
Authority Report (see paragraph 8.4.2), or similar.
- consulting with the relevant Notified Body on matters relating to the conformity
assessment; consulting the Commission, for example if it is considered that
re-classification of the device is necessary;
- further user education;
- further recommendations to users;
- any other action to supplement manufacturer action.
8.3.5 The Competent Authority may take action in accordance with Article 2 of either
Directive, or in accordance with Article 7 of the AIMD or Article 8 of the MD.
8.3.6 The Competent Authority should consider whether action needs to be taken on
similar devices, made by the same or different manufacturer.
8.4 DISSEMINATION OF INFORMATION BETWEEN COMPETENT AUTHORITIES
8.4.1 Information should be disseminated between Competent Authorities and copied
to the Commission for incidents where:
- corrective action (including recalls) is to be taken;
- there is a serious risk to the safety of patients or other users, but where no
corrective action has yet been established although measures are under consideration, or
where there is not yet a final report from the manufacturer
8.4.2 A recommended format for dissemination of information, using a "Competent
Authority Report" and notes for completion of the report are given at Appendix 8. The
manufacturer's report may be circulated with the Competent Authority Report.
The appropriate "reason for report" should be identified on the Competent
Authority Report. Competent Authorities receiving reports should pay particular attention
to the "reason for report" and any recommendations" given by the Competent
Authority issuing the report. A number of reports may not require any immediate further
action. Wherever possible, Competent Authorities should direct enquiries arising from the
report to the Competent Authority providing the notification, who will co-ordinate
communication with the manufacturer or Notified Body.
8.4 3 Competent Authority Reports are intended for dissemination between Competent
Authorities and the Commission only, and are not for onward distribution to users or other
interested parties..
8.4.4 Competent Authorities should consult the manufacturer when preparing a report,
and should inform the manufacturer when one is issued.
8.5 DISSEMINATION OF INFORMATION OUTSIDE COMPETENT AUTHORITIES
8.5.1 Careful consideration should be given to the drafting and the dissemination
of information by the Competent Authorities. The possible positive and negative effects of
the information to be disseminated should be considered when drafting advisory
notifications and when selecting the means and medium by which the message is transmitted.
Preference should be given to notification directly to medical practitioner or
health-care facilities concerned.
Medical practitioners or other health-care professionals should be consulted where
appropriate.
The manufacturer should be consulted wherever practicable.
8.5.2 In exceptional circumstances, and only if other means are not appropriate,
dissemination of information direct to the public may be needed. The purpose of such
communication will normally be to suggest that patients or users contact their medical
practitioner for further, more specific advice
8.5.3 Consideration should be given to the preparation of a statement to the press for
use by all Competent Authorities,
8.5.4. The above considerations apply also to dissemination of information by the
manufacturer in consultation with the Competent Authorities.
8.5.5 Interfaces with communication media should be coordinated wherever practicable
between the manufacturer and the Competent Authorities.
8.6 SAFEGUARD CLAUSE
The application of the Vigilance system does not affect the
responsibilities of the Member States laid down in the Safeguard Clause (Article 7 of AIMD
and Article 8 of MDD).
The Safeguard Clause procedures remain applicable regardless of the Medical Devices
Vigilance system.
8.7 COMPLETION OF THE INVESTIGATION AND CLOSURE OF THE FILE
8.7.1 The Competent Authority should place the manufacturer's final report on file
and make any other observations necessary. The file may then be endorsed as
"closed".
8.7.2 If a Competent Authority itself conducts an investigation, the manufacturer (and,
where appropriate, other Competent Authorities) should be informed of progress and of the
results.
8.7.4 The final report should also be copied to any Competent Authorities who were
informed of the initial report.
8.7.5 It is possible for a file to be "closed" with no further action after
the initial report of the incident
8.7.6 The Competent Authority should inform the manufacturer when a file is closed
8.7.7 Files where action is complete, or for which no further action is intended,
should be retained as it is possible that changing circumstances may cause the matter to
be re-opened
Return To Previous Page
|
