The European Commission is calling for applications from stakeholder associations to select observers to the Annex XVI subgroup of the Medical Devices Coordination Group. This group is tasked with developing the technical requirements for the product groups set out in Annex XVI.
This working group’s key function is to advise the Commission on matters relating to the application and implementation of the general safety and performance requirements set out in Annex I of (EU) 2017/745 as well as the general obligations of economic operators laid down in Chapter II with reference to the Annex XVI devices.
In addition, the group will contribute to the development of guidance documents concerning the application of requirements mentioned above with particular reference to the qualification of products and technical aspects.
Applications can be submitted using the online application form. The closing date for submission of completed applications is 28 February 2020.
Further information is available from the Commission website. There is also an information leaflet with further details on what’s involved.