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Call for applications: observers for the Annex XVI sub-group of the medical device coordination group

This is an updated version of the call replacing the version published on 27/01/2020. Deadline for submission of applications is extended until 6 March 2020. To ensure the necessary technical input for the group of products mentioned in Annex XVI of Regulation (EU) 2017/745 on medical devices, the European Commission is calling for applications from stakeholder associations to select observers to the Annex XVI sub-group of the medical devices coordination group (MDCG).

Related topics

Medical devices

Deadline:  06/03/2020

This working group will assist and advise the MDCG on all implementation issues related to the group of products mentioned in Annex XVI of (EU) 2017/745.

In particular, the working group will advise on matters related to

  1. the application and implementation of the general safety and performance requirements set out in Annex I of (EU) 2017/745 for devices included in Annex XVI
  2. the general obligations of economic operators laid down in Chapter II of (EU) 2017/745 with reference to Annex XVI devices
  3. the development of guidance documents concerning the application of requirements mentioned in point (i), with particular reference to the qualification of products and technical aspects

The submission deadline for this call is extended until 6 March 2020.

See the call and terms of reference