European Commission Calls for Observers to Join Annex XVI Subgroup

Regulatory NewsRegulatory News
| 30 January 2020 | By Michael Mezher 

The European Commission this week called for applications for observers to the Annex XVI subgroup of the Medical Device Coordination Group (MDCG) to provide technical input on medical devices without an intended medical purpose under the Medical Devices Regulation (MDR).

Annex XVI of the regulation lists six groups of medical devices that do not have an intended medical purpose, including contact lenses and aesthetic devices.

The Commission says the working group will provide advice on applying safety and performance requirements described in Annex I of MDR, the obligations of companies under Chapter II and the development of guidance on those requirements for devices listed under Annex XVI.

The call for observers comes just after the MDCG announced a slate of meetings for 2020, including a 4 May meeting on Annex XVI.

Interested parties are instructed to submit an application by 28 February 2020 to be considered as observers.

European Commission


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