Essentials of European Medical Device Regulatory Affairs

Establish post market surveillance system

May include:- –

Vigilance process

FSCA process

– – – – –

User / Patient group feedback User / Patient Questionnaires

Input from Scientific Advisory Boards

Post Market Clinical Follow Up

– Remember you may be restricted from direct patient contact – Remember GDPR may affect what you hold as data

Conduct Risk Assessment

ISO 14971 Harmonised standard

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• Risks need to be eliminated or reduced risk as far as practicable • Any remaining residual risk must be outweighed by the benefits associated with the device – risk benefit analysis. • Risk Assessment required throughout the product life cycle -Pre market AND post market.