The Medical Devices Introductory Course 2020

The Organisation for Professionals in Regulatory Affairs

• The role of a Notified Body (NB) in Europe • Notified Body is designated by a competent authority to act on it behalf • Under IVD Regulation devices of Class B, C and D require NB interaction. (IVDD 10% vs IVDR 90% NB interavtion) • Level is risk based • B & C devices reviewed and certified on a sampled basis • All self tests and devices with sterile requirements are reviewed and approved by NB • All class D reviewed and approved by NB • NB also reviews the Quality Management System for compliance against IVDR Conformity Assessment – Third Party interaction

The Organisation for Professionals in Regulatory Affairs