Essentials of European Medical Device Regulatory Affairs - June 2020

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 Guidanceon law (e.g. classification) • Can ask the EU Commission for a classificationdecision • Inspect, Audit and “deNotify” NB , includingduringNB activities • Can inspect class I Manufacturers • Surveillance responsibilities

• Oversees that manufacturer investigates serious incidentsand implements corrective action (if necessary) • Informs other EU countrieswhen a local manufacturer has a corrective action

• Authorisationof clinical investigations • On going post-market communications– certificates withdrawn,suspended • Maintains nationaldevice register (class I databaseand EUDAMED)

TheOrganisation for Professionals in Regulatory Affairs

Notified Body (NB)

• Evaluatemanufacturer’s compliance to legislation • Issue certification (EC) topermit CE marking of a device • NB’s tend to be private sector companies • Companychooses its NB body:provided they are designated in thatdevice area. • IMPACT OF BREXIT in choice of NB • NB fees should be publicly available • NBs listed per directive • http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13 • NationalStandardsAuthorityof Ireland (NSAI)

1SwiftSquare,Northwood,Santry, Dublin9, Ireland Phone :+353.1.807.38.00 Email : info@nsai.ie Website : www.nsai.ie NotifiedBody number :0050

Lists the Notified Body requirements/obligation

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AnnexVII

TheOrganisation for Professionals in Regulatory Affairs

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Considerations for choosing a NB:

Are they designated under the MDR?

– –

Do they have the right scope?

– Is my NB sustainable? Multisite? Resource? Brexit? – Can I work with these people? – Do these people understand my technology? – Do we share: testing, validation & clinical approach? – Will their reputation enhance mine? – Will there be language issues? – What is the time and cost – will quotes hold? – Consider who your contractors and competitors use • Factor into your product launch plans!

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