Essentials of European Medical Device Regulatory Affairs

Competent Authority (CA) Role

Government agency per EU country responsible for Medical devices • Interpretation and Guidance on law (e.g. classification) • Inspect, Audit and can “deNotify” Notified Bodies in juristriction • Can inspect class I Manufacturers • Surveillance responsibilities – Oversees that manufacturer investigates serious incidents and implements corrective action (if necessary) – Informs other EU countries when a local manufacturer has a corrective action • Authorisation of clinical investigations • On going post-market communications – certificates withdrawn, suspended • Maintains national device register (class I database and EUDAMED)

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Notified Body (NB) Private Bodies who offer conformity assessment services • Evaluate manufacturer’s compliance to legislation • Under the jurisdiction of their National Competent Authority • Member States are not obliged to appoint a NB and may appoint any number of NBs • Company chooses its NB body: provided they are designated in that device area. – NBs designation and scope listed per directive/ regulation: http://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=1 3

• NB may sub contract but retains responsibility • Involvement increases with higher classification • NB number appears on labelling where involved in Conformity Assessment

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