Under the EU MDR and IVDR, the MDCG (Medical Device Coordination Group) provides advice and assists the European Commission and the Member States in ensuring a harmonised implementation of the Regulations.
The MDCG can establish sub-groups to receive their in-depth technical expertise. Where appropriate, stakeholder organisations may be appointed as observers in the sub-groups.
A call to stakeholders has opened to select observers to the MDCG Annex XVI sub-group:
”The working group shall provide assistance and advice to the MDCG on all implementation issues related to the development of common specifications for those groups of products listed in Annex XVI of the Regulation (EU) 2017/745 for which a manufacturer claims only an aesthetic or another non-medical purpose.
In particular, the working group shall provide relevant advice in matters related to among others, with an analysis of:
(i) the application and implementation of the general safety and performance requirements set out in Annex I of the MDR for Annex XVI devices;
(ii) general obligations of economic operators laid down in Chapter II of the MDR with reference to Annex XVI devices;
(iii) development of guidance documents concerning application of requirements mentioned in point (i), with particular reference to qualification of products and technical aspects.
The working group shall prepare draft guidance for endorsement by MDCG the field of its activities.”
Who can apply?
Organisations representing the interests of the medical device industry, other economic operators, healthcare professionals, conformity assessment bodies, hospitals, laboratories, patients and consumers at Union level are invited to submit their application to DG SANTE.
When applying the following categories can be chosen: Academia, Research Institutes and Think Tanks, NGOs, Professionals’ associations, Professional consultancies, Trade and business associations, Trade unions, Other.
The call closes on 28 February 2020, apply here!