24 Jul European Commission calls for observers to the nomenclature subgroup of the medical devices coordination group
The European Commission has launched a call for observers to support the nomenclature subgroup of the Medical Device Coordination Group (MDCG).
This call is made in order to ensure the necessary technical support for the nomenclature of medical devices. The observers’ tasks will include advising the MDCG on implementation issues related to medical device nomenclature to support the future EUDAMED medical device database, which has already been discussed in this blog.
In particular, the observers will advise the medical devices coordination group on issues related to the update and maintenance of the EU nomenclature, which are covered by Article 26 of Regulation (EU) 2017/745 (MDR) and Article 23 of Regulation (EU) 2017/746 (IVDR). Observers should also advise on ways to use the nomenclature in the Unique Device Identification (UDI) registry, e.g. in market surveillance.
Industry associations and other health professionals or interested parties have until 5 August to submit applications. The EC Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) will select observers to form the MDCG nomenclature working group.
DG GROW will consider, for each candidate, the link between the mission and objectives of the partnership and the activities of the working group, the relevant competence and experience of the partnership and the ability to represent the interests of stakeholders and member states. The selection criteria will also include the importance and impact of the association’s activities at European level, English language proficiency and the “competence, experience and hierarchical level of the proposed representatives”.
The call specifies that observers will be appointed for an initial period of five years. You can find the ranking form, the selection criteria and explain how personal data will be protected.