Regulatory Focus™ > News Articles > 2019 > 7 > EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup

EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup

Posted 09 July 2019 | By Ana Mulero 

EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup

The European Commission (EC) issued a call for applications to serve on a subgroup that will assist and advise on nomenclature-related issues, including unique device identification (UDI) and surveillance, as part of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).
 
The 5 July call gives industry associations and other health professionals or stakeholders until 5 August to submit applications. The EC’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) will select the observers to form the Medical Device Coordination Group (MDCG) nomenclature working group, which is expected to support the future Eudamed, a database on medical devices.
 
The search for observers is intended to ensure “the necessary technical input,” the EC notes.  The subgroup will not only be charged with helping the MDCG address implementation issues, but also with advising the MDCG on ways to update and maintain the nomenclature.
 
To help determine whether an applicant would qualify as an observer, DG GROW will consider the link between an association’s mission and objectives and the working group activities, an association’s relevant competence and experience and the ability to represent stakeholders’ and member states’ interests. Selection criteria also concern the significance and impact of an association’s activities at the European level, proficiency in the English language, and the “competence, experience and hierarchical level of the proposed representative(s).”
 
The call further specifies the application process, the procedures for selected observers to be appointed for an initial five-year period and the rules of engagement. Annexes provide a classification form and a selection criteria form and explain how personal data will be protected.
 
In notifying of its decision in March to map Italy’s National Classification of Medical Devices to the Global Medical Device Nomenclature, the EC said the subgroup of the MDCG nomenclature working group will be established “to the purposes of providing better regulatory oversight over the EU nomenclature system.” The EC also drew up the Eudamed functional specifications in March. Eudamed guidance followed on registration, UDI and data exchange.
 
EC Call for Applications

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe