Updates included:  Templates for Manufacturers Trend Reporting and Manufacturers Periodi

Updates included:

• Templates for Manufacturers Trend Reporting and Manufacturers Periodic Summary Reporting are included in this guidance; these templates are based on Global Harmonization Task Force (GHTF) documents, demonstrating the European Union’s ongoing commitment to the GHTF’s principles.

• The Medical Device Vigilance System guidelines emphasize issues such as use error during evaluation of criteria that may constitute an incident, as well as provide examples of Field Safety Corrective Action reports (Annex 1) and how to further involve users in the vigilance process (Annex 11).

• Furthermore, guidelines for reporting incidents to regulatory authorities in Turkey have been included for manufacturers active in that market.

• Guidelines also expand in-vitro diagnostics (IVD) classification criteria to include devices not used directly on patients, as well as IVF/ART.

• Additional requirements for Competent Authorities to use the EUDAMED database for exchanging NationalCompetent Authority Reports (NCARs) in order to provide better coordination with

Commission Decisions.

MEDDEV 2.12.2, Rev. 2: Post Market Clinical Follow-Up Study Guidelines

The January MDEG meeting also dealt with amendments to post-market clinical follow-up (PMCF) that were stipulated byDirective 2007/47/EC. Revised PMFC guidelines address the monitoring of long-term risks that may not be immediatelyapparent for some medical devices, recommending when PMCFs are warranted; general principles of PMCFs; proper use of clinical study data; and the PMCF role in Conformity Assessment Procedures.

MEDDEV 2.5.10, Rev. 1: AuthorizedRepresentative Guidelines

Also issued during the MDEG meeting were finalized guidelines (MEDDEV 2.5.10, Rev. 1) for Authorized Representatives (AR). Intended to clarify AR roles and responsibilities within the European Union medical device regulatory regime, the guidelines define E.U. member states’ expectations of ARs and strongly recommend use of written contracts between ARs and the manufacturers they represent in order to clearly delineate responsibilities carried out by ARs (such asAR agreements).

The guidelines also emphasize that device manufacturers and their ARs must make every attempt to keep one another informed of all issues related to products they have commercialized in the European Union. Expectations that member states receive all information they request from ARs is made clear in the guidelines; accordingly, manufacturers must ensure that all device data they possess internally is made available to their ARs.

MEDDEV 2.2.4: IVF/ART Conformity Assessment Guidelines

MEDDEV 2.2.4 Conformity Assessment guidelines for IVF/ART devices apply PMCF, traceability and vigilance principles to these increasingly popular products in accordance with Directive 93/42/EEC. E.U. regulators considered guidance for IVF/ART devices necessary because safety issues may not arise until months or years after use of such a device. Furthermore, the guidelines list risks specifically tied to use of IVF/ART devices.

MEDDEV 2.14.1, Rev. 2: In-Vitro Diagnostic Medical Device Borderline and Classification Revisions

The January MDEG meeting also saw a substantial revision of MEDDEV 2.14.1 dealing with IVD classification—now a 21-page document, from eight pages in its previous iteration. Now MEDDEV 2.14.1 more closely resembles guidance on the classification of medical devices (MEDDEV 2.4.1, Rev. 9).

Specific IVD products and components covered in the guidance include:

• Specimen receptacles;

• Products to obtain specimens;

• General laboratory use products;

• IVD kits;

• Microbiological culture media;

• Stains; and

• Devices requiring invasive body contact with no IVD purpose.

Also included in the revised MEDDEV 2.14.1 are classification issues concerning some IVD products in Annex II, Lists A and B of 98/79/EC.