Module 16 2024

18/10/2024

MDR requirements supporting PSUR

Definitions

MDR Article 2 (60) ‘post - market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

MDR Article 2 (60) ‘market surveillance’ means the activities carried out and measures taken by public authorities (Competent Authorities) to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

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MDR requirements supporting PSUR

Article 83: Post-market surveillance system of the manufacturer

Article 84: Post-market surveillance plan

Article 85: Post-market surveillance report

Article 86: Periodic safety update report

Article 91: Implementing acts

Article 92: Electronic system on vigilance and on post-market surveillance

Annex III: Technical Documentation on Post-market Surveillance

Annex XIV: Clinical Evaluation and Post-Market Clinical Follow-Up

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