Essentials of European Medical Device Regulatory Affairs - June 2020

Establish Quality Management System (QMS) Key elements required by the MDR Article 10: a) Regulatory strategy for compliance b) GSPRs c) Management responsibility d) Resource management

Can I use ISO 13485?

e) Risk management f) Clinical evaluation g) Product realization h) Verification of UDI i) PMS system j) Communications with CAs NBs EOs… k) Vigilance l) CAPAs m)Product improvement

 Harmonised standard  Covers many required elements ! Need to add EU specific elements

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Economic operators Manufacturer

The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name , regardless of whether these operations are carried out by that person himself or on his behalf by a third party Obligations • Manufacturers need to draw up the appropriate documentation and amend it as standards change, and the product changes

• Manufacturers need a quality management system to manage processes (e.g. reporting obligations)

European Authorised Representative (AR) • If manufacturer is outside community they need a natural or legal person to act on their behalf. • Article 11 describes obligations. Record in the mandate between AR and manufacturer tasks. • A UK AR is no longer possible post BREXIT. Person responsible for regulatory compliance (PRRC) • Manufacturer needs someone responsible for compliance of MDR(PRRC-m) and the AR needs access to someone in the community (PRRC-AR).

MDCG 2019-7Guidance onArticle 15 of theMedicalDevice Regulation (MDR)and in vitroDiagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC)

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