Framework
EUMDR — Market Access
The EU MDR 2017/745 defines the requirements for placing medical devices on the European market, including conformity assessment procedures, CE marking, and the EU declaration of conformity. It establishes the roles and responsibilities of economic operators, the involvement of notified bodies, and the conditions under which devices may be legally made available on the EU market.
Overview
Background
Regulation (EU) 2017/745 replaced the Medical Devices Directive (93/42/EEC) with a more rigorous market access framework. The regulation introduced stricter conformity assessment procedures, enhanced notified body oversight, and new requirements for clinical evidence, reflecting the EU's commitment to ensuring only safe and effective devices reach patients.
Applicability
These requirements apply to manufacturers, authorized representatives, importers, and distributors of medical devices intended for the EU market. The conformity assessment route depends on the device risk classification (Class I, IIa, IIb, or III). All devices must bear CE marking and be accompanied by an EU declaration of conformity before being placed on the market.