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
- 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
- the general obligations of economic operators laid down in Chapter II of (EU) 2017/745 with reference to Annex XVI devices
- 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.