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New IMDRF category – Affiliate members

Posted on 02.02.2023

With a statement on their website, the Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF) has recently announced that a new membership category is now available, allowing regulatory authorities who do not yet meet the criteria of Official Observer or Invited Observer but would like to engage with IMDRF to become an IMDRF Affiliate Member.

The IMDRF Standard Operating Procedures have been updated accordingly (new version here). As illustrated in Section 3.4, as an Affiliate Member, “the regulatory authority will participate in IMDRF by attending “open” meetings and using IMDRF documents in part or in whole as the basis for their own regulatory framework. Affiliate Members may also participate in open Working Groups. Affiliate Members do not participate in the decision-making process of IMDRF. Affiliate Members must be approved by unanimous consent of the IMDRF MC”.

For more information, please contact Dario Belluomini, Manager International Affairs.