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Publications

EDMA Documents

In order to keep our members informed of the developing regulatory issues EDMA produces and maintains a series of different documents for the use of its members. In the menu on the left, please find links to all recent EDMA publications. If you have any questions regarding a certain publication, please do not hesitate to contact a member of the EDMA Secretariat for more information.

Position Papers

EDMA position papers are produced to disseminate the consensus position of our members as regards to a given issue. They provide a valuable tool to allow EDMA members to communicate the opinions of the IVD industry to any interested party. They are drafted by the EDMA Task Force with expertise on the subject and then referred to the Regulatory Affairs Committee, the Executive Committee, NAMs and CAMs.

Position Papers are publicly available documents which can be distributed to any interested party.

Guidance Documents

EDMA guidance documents are produced to aid our members in dealing with specific issues. Guidance documents are drafted by the EDMA Task Force with expertise on the subject and then referred to the Regulatory Affairs Committee, the Executive Committee, NAMs and CAMs for approval.

Please note: Guidance documents are internal EDMA documents for members only!

Questions & Answers

The EDMA Q&A cards have been developed by the EDMA Technical Forum to answer questions frequently asked in relation with the IVD Directive. The objective is to use them as a tool to better understand the directive. As new issues arise, new cards are developed.

These Q&A cards are developed for EDMA members and available to EDMA members, but if required they can be presented to other Medical Devices Associations, to the EU Commission or other decision making bodies and to notified bodies as part of industry efforts to get a reasonable interpretation of grey areas. Q&A cards do not deal with contentious issues - these are dealt with by Position Papers prepared by EDMA.

EDMA Regulatory News

To keep the EDMA members informed on development in key issues EDMA produces regulatory news on specific issues of interest. These documents deal with a great variety of issues which are of interest to our members and are sorted by category. (For instance legislation news, environmental news, etc.) They are generally produced at the request of the EDMA task forces or in response to some development which may be of interest to EDMA members.

Please note: Most EDMA news are reserved for members only, however in exceptional instance and upon the request of our members some newsletters may be made publicly available.

Annual Reports

A look at the activitites and accomplishments of EDMA.