Framework
EUMDR — Technical Documentation
The EU MDR 2017/745 Technical Documentation requirements define the comprehensive documentation package that manufacturers must compile and maintain for medical devices. This covers Annexes II and III of the regulation, specifying the device description, design and manufacturing information, safety and performance data, benefit-risk analysis, and product verification and validation evidence.
Overview
Background
Established under Regulation (EU) 2017/745, the Medical Device Regulation replaced the former Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). The technical documentation requirements are significantly more detailed than those under the previous directives, reflecting a heightened emphasis on transparency, traceability, and lifecycle management.
Applicability
These requirements apply to all manufacturers placing medical devices on the EU market, regardless of device risk class. The technical documentation must be prepared before the device is placed on the market and maintained throughout the device's lifecycle. Authorized representatives, importers, and notified bodies also interact with this documentation during conformity assessment procedures.