News about GMP/cGMP

07.06.2019

EC: 20 Questions & Answers about Notified Bodies

On 6 June 2019, the European Commission published a Q&A document to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs).

The 8-page document has been endorsed by the Medical Device Coordination Group (MDCG). The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

It answers four sets of questions on a range of MDR/IVDR requirements relating to NBs. The clarifications cover organizational and general requirements, as well as resources requirements and process requirements.

Other questions and answers under organizational and general requirements relate to the meaning of the terms “legal personality,” “organization” and “organizational structure” under MDR/IVDR, as well as the clearance of consultants per Regulation (EU) 920/2013, pre-certification services, new conditions on remuneration, absence of conflict of interests declarations and evidence of individual liability insurance.

The MDCG emphazises that a NB cannot accept any application under MDR or IVDR before a designation becomes valid on the day after the notification is published in the EC’s NB database, known as NANDO.


Sources:

RAPS: Regulatory News

European Commission: DocsRoom



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