Essentials of European Medical Device Regulatory Affairs

Competent Authority (CA) Role Government agency per EU country responsible for MD directives • Notifies Bodies to the EC based on assessed ability (NB) • Interpretation and Guidance on law (e.g. classification) • Can ask the EU Commission for a classification decision – (MDEG) • Inspect, Audit and “deNotify” NB , including during NB activities • 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a  corrective action • Authorisation of clinical investigations • On going post‐market communications – certificates withdrawn, suspended • Maintains national device register (class I database and EUDAMED)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) • Evaluate manufacturer’s compliance to legislation • Issue certification (EC) to permit CE marking of a device • NB’s tend to be private sector companies • Company chooses its NB body: provided they are designated in that device  area. • NBs listed per directive • http://ec.europa.eu/growth/tools‐databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13 • National Standards Authority of Ireland (NSAI)

1 Swift Square, Northwood, Santry, Dublin 9, Ireland Phone : +353.1.807.38.00 Email : info@nsai.ie Website : www.nsai.ie Notified Body number : 0050

• NB may sub contract but retains responsibility • Involvement increases with higher classification • NB number appears on labelling  • IMPACT OF BREXIT in choice of NB

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