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Medical Device Regulation

Regulation (EU) 2017/745 on medical devices entered into force on May 25, 2017. It is known as the European Medical Device Regulation (MDR). It applies directly in the Member States of the European Union and therefore does not need to be transcribed into national law

Based on a high health protection level for patients and users, MDR ensures a seamlessly functioning internal market for medical devices while taking into account the small and medium-sized companies that operate in this sector. This regulation also sets down standards for the quality and safety of medical devices, which addresses general safety concerns about these products.

To improve health and safety, key elements of the current regulation concept, such as the supervision of notified bodies, the conformity assessment procedure, clinical tests and clinical evaluations, vigilance, and market supervision are significantly increased and provisions implemented to ensure transparency and traceability in relation to medical devices.

Apart from a small number of exceptions, the regulation on medical devices applies from May 26, 2020, and the regulation on in vitro diagnostic medical devices from May 26, 2022. Both regulations will replace the medical devices directives 90/385/EEC and 93/42/EEC and the directive on in vitro diagnostic medical devices 98/79/EC. They apply directly in the Member States of the EU and therefore do not need to be transcribed into national law.
Glossary Technical terms at a glance

M

Malfunction analysis MDD-Directive MDR Measurement System Analysis Mechatronic FMEA Mechatronics Medical device Medical Devices Act Medical Device Regulation

O

One Piece Flow Operating period Operating state

P

PDCA PDCA cycle Poka-yoke Population PPAP Product development process Production control plan Property

Q

QFD QMS Quality Quality management Quality management standard