EU MDR requirements explained: video brief

Classification and the quality management system

The Medical Device Regulation runs to 123 articles and seventeen annexes, but the obligations that shape a manufacturer's programme sit in about a dozen of them. This short film maps them. Annex VIII classifies each device as class I, IIa, IIb or III under twenty-two rules, by intended purpose and inherent risk; the class fixes the conformity route and whether a notified body is involved. Plain class I devices self-declare, while sterile, measuring and reusable surgical class I devices need a notified body.

Article 10 and Annex IX require the manufacturer to establish, implement, maintain and continually improve a quality management system covering at least thirteen aspects, from the regulatory compliance strategy and resource management to product realisation, post-market surveillance, vigilance and corrective and preventive action.

Evidence, traceability and life after launch

Clinical evaluation must show, with sufficient clinical evidence, that each device meets the general safety and performance requirements and the evaluation is updated throughout the device's life on the market. Technical documentation sets out the device, its labelling, design and manufacture, the requirements met, risk management and verification and validation. Traceability comes from unique device identification and EUDAMED registration, and the manufacturer names a person responsible for regulatory compliance.

After launch, post-market surveillance, vigilance reporting and periodic safety update reports or post-market surveillance reports continue for the life of the device. The Regulation has applied since 26 May 2021 and has been amended by later regulations extending transition periods. A notified body designated for the MDR assesses devices above plain class I, and the manufacturer signs the EU declaration of conformity and affixes the CE mark; there is no MDR certificate as such.

Every manufacturer needs at least one person responsible for regulatory compliance with the qualifications in Article 15; micro and small enterprises may have one permanently at their disposal rather than employ them. Notified bodies are listed with their scopes in the Commission's NANDO database. An ISO 13485 certificate gives a presumption of conformity only for the requirements it covers, not for UDI, vigilance or EUDAMED.