The European Union's medical device regulation framework.
EU Medical Device Regulation (MDR) 2017/745 governs the manufacture and sale of medical devices in the European Union, replacing the Medical Device Directive (MDD). It significantly increased documentation requirements compared to its predecessor — particularly for clinical evidence, post-market surveillance, and technical documentation.
MDR requires manufacturers to maintain a Technical Documentation file for each device, including a Clinical Evaluation Report (CER) demonstrating clinical safety and performance, Post-Market Clinical Follow-Up (PMCF) plans and reports, Post-Market Surveillance (PMS) plans, and a Summary of Safety and Clinical Performance (SSCP). The documentation burden is substantially higher than under MDD — a significant challenge that has delayed CE marking for many manufacturers.
General Safety and Performance Requirements documentation — device risk management aligned with ISO 14971.
Device description, design documentation, labeling, intended purpose, and clinical evaluation.
Clinical Evaluation Plan, Clinical Evaluation Report, PMCF plan and report.
Clinical investigation plan and report documentation if required.
Summary of Safety and Clinical Performance for implantable and Class III devices.
Unique Device Identification labeling documentation and EUDAMED registration records.
Templates and implementation resources for EU MDR 2017/745 are available through the ELDR Institute Knowledge Hub and via direct request.