In brief
An MDR medical device is a product that the manufacturer intends for a medical purpose (for example, to compensate for a disability) and places on the EU market in compliance with Regulation (EU) 2017/745, with CE marking and technical documentation.
Regulation (EU) 2017/745
The MDR (Medical Device Regulation) governs medical devices in the European Union. It has applied since 26 May 2021 and replaced Directive 93/42/EEC and Directive 90/385/EEC.
What "intended purpose" means
The manufacturer defines the intended purpose of the product. If it falls within the medical purposes set out in the Regulation, including the compensation of a disability, the product is a medical device and must meet its requirements.
Risk classes
Devices are divided into classes (I, IIa, IIb, III) according to risk, following the rules in Annex VIII. The class determines the conformity assessment procedure.
Main manufacturer obligations
- Technical documentation and clinical evaluation
- Quality management system
- EU declaration of conformity and CE marking
- UDI identification and EUDAMED registration within the required timelines
- Post-market surveillance
Why it matters to buyers
Medical device status can be relevant, for example, for certain tax benefits. It should always be checked against the official documentation of the specific product.
