New expert group under MDR

A new expert subgroup of the MDCG was established to cover Annex XVI products; therefore issues with products without an intended medical purpose but falling under the applicability of the new Regulation on medical devices.

The new expert group called ”Annex XVI”, will gather experts representing competent authorities of the EU Member States. As all the rest of the already established working groups (now 12 in total), ”Annex XVI” group will provide its expertise to the MDCG that assists the European Commission and the EU Member States in the implementation of both Regulations.

When the European Commission publishes the group’s Terms of Reference, e.g. tasks, membership, meetings, you will be informed on this blog!

On the following link, you can also scroll through published minutes, members and observers to the MDCG and its subgroups.

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