Essentials of European Medical Device Regulatory Affairs - June 2020

Annex 2

Technical Documentation

Device description and specification, including variants and accessories 1. Information to be supplied by the manufacturer 2. Design and manufacturing information

3. General safety and performance requirements 4. Benefit-risk analysis and risk management 5. Product verification and validation 6.1 Pre-clinical and clinical data 6.2 Additional information required in specific cases And keep with it the PMS documentation Annex III : – PMS Plan – PMCF Plan – PSUR or PMS report

TheOrganisation for Professionals in Regulatory Affairs

Conformity Assessment

TheOrganisation for Professionals in Regulatory Affairs

Process (Conformity Assessment) Definition: MDR article 2 (40) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

TheOrganisation for Professionals in Regulatory Affairs

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