Vigilance News

1. Report of the meeting of the Post-Market Surveillance and Vigilance Working Group (Sub-group of the MDCG*).

*Medical Device Coordination Group

1. Addendum relating to the Vigilance System as defined in the MEDDEV Guide 2.12-1 Ver. 8,
2. EU and IMDRF (International Medical Device Regulators Forum) NCAR (National Competent Authority Report) forms.

1. The first meeting of the Post-Market Surveillance and Vigilance Working Group took place on 5 March 2019 with representatives from Member State authorities and stakeholder organisations.

1. This addendum dated 7 May 2019 provides additional information on the Medical Device Vigilance System currently used in accordance with MD Directives. It must be used in conjunction with the MEDDEV Guide 2.12-1 Ver. 8 2013.

1. NCAR forms:

• The EU NCAR form must only be used between Competent Authorities of the EU and the Commission.
• The IMDRF NCAR form must only be used for exchanges with Competent Authorities located outside the EU. Completed forms must not be made public.

Analysis

1. Meeting of the WG (Working Group] on Post-Market Surveillance and Vigilance, the main themes addressed were the following:

• MIR (Manufacturer incident report) :

The new MIR form will come into force from 1 January 2020. Discussions were mainly on the operators authorised to report serious incidents on Eudamed: i.e. manufacturers, or their agents, or a third party on behalf of the manufacturer but no other operator (distributors, importers).

A single operator (per device) must be responsible for recording incident reports on Eudamed to avoid double reporting.

• MPSR (Manufacturer Period Summary Report) :

The MPSR has been finalised. It will only be applicable as part of the MDR. It must be approved by the MDCG, so that a guide can them be drawn up and the form and guide published on the Web Europa website. A simplified MIR form is in the process of being drawn up as part of Eudamed: it is to be transmitted periodically to the CA (Competent Authorities) that have approved the MPSR.

• PSUR (Periodic Safety Update Report) :

The PSUR currently under development must apply only to MDs under the MDR certificate.

• FSCA (Field Safety Corrective Action) :

The Working Group concluded that it was not possible to have a form but that direct integration within Eudamed is possible.

• IMDRF adverse event nomenclatures:

Nomenclatures have been approved by the IMDRF Management Committee. A 12-month transition period is planned for the industry after the future publication of the nomenclatures by the IMDRF. A web browser must be developed to facilitate the choice of terms and appropriate codes.

• Addendum to the Meddev Guide on Vigilance:

This addendum (see part 2) concerns only the MD Directives. It has also been agreed to launch new guides on PMS and Vigilance for the implementation of the MDR and IVDMDR.

• Public access to vigilance data:

The objective is to give the public and healthcare professional widespread access to Eudamed data without reducing the level of information required of manufacturers in their incident reports by Competent Authorities. A Working Group has been created to submit proposals to the MDCG. All stakeholder organisations of the WG responsible for Vigilance must be consulted in advance to define these proposals.

1. Addendum to Meddev Guide 2.12.1 Ver. 8

Its objectives:

• Clarify certain existing definitions,
• Introduce the new Manufacturer Incident Report (MIR) and the new model Field Safety Notice (FSN),
• Introduce a vigilance guide specific to the device,
• Provide additional details on the coordination of vigilance issues between Competent Authorities.
• Clarify the differences between the EU and IMDRF version report exchange forms between Competent Authorities (NCAR) (see part 3).

This document also states that the latest version of the forms currently covering the Medical Device Vigilance System can now be consulted on the European Commission website, and not in the appendices of MEDDEV 2.12-1 Ver. 8 2013.

1. NCAR information exchange forms

Exchanges by issuing CA located in the EU must be carried out:

• Via the EU NCAR form for exchanges inside the EU,
• Via the IMDRF NCAR form for exchanges outside the EU.

NCAR forms must not be used to report isolated incidents unless they have clear repercussions for public health.

The Competent Authority that completes the NCAR must:

• Be clearly identified in the relevant section of the form,
• Ensure the accuracy, exhaustivity and relevance of the content of the information distributed,
• Specify whether the information provided can be published or whether it must remain strictly EU confidential,
• Specify whether distribution is restricted (between certain members of the NCAR programme) or unrestricted (concerning all members) IMDRF.

If the NCAR concerns a specific device, the manufacturer or its authorised representative can be consulted in advance concerning the content and distribution of the NCAR. This process must help guarantee accuracy, in particular in terms of the NCAR’s technical content.

The deadline by which manufacturers must return their comments must be specified.

EU specific:

EU States must exchange NCAR report, from the Eudamed database, in accordance with the European Directives in force. More rarely, if a major threat to public health should occur, issuing CA can send reports directly to other Member States concerned.

The countries in which the device is distributed are listed, as are the recipients of the NCAR.

IMDRF specific:

The aim of the exchange must be specified:

1. Information sharing, or
2. Information request, or
3. Survey results summary.

For information requests (2), a feedback deadline must be specified by the issuing CA. A question and answer section is planned.