Essentials of European Medical Device Regulatory Affairs

Define intended purpose of the device

‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the labelling , in the instructions or in promotional or sales materials or statements and as specified… in the CER”

intended use indications contraindications warnings and precautions claims and benefits

who user whom patient

expertise

population where environment environment when concomitant compatibility

Align marketing materials with technical information and CER – Needs upfront agreement and documentation in the tech file – Needs approval process with regulatory review to prevent ‘drift’

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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

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

Can I use ISO 13485?

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

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