Medical Devices Regulation
The Medical Devices Regulation (MDR, Regulation (EU) 2017/745) establishes requirements for medical devices placed on the EU market. It requires CE marking, notified body involvement for most device classes, and an EU Authorised Representative for non-EU manufacturers — distinct from the GPSR EU AR.
EU Regulations Overview
Medical devices as defined in the Regulation, including devices intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease. Classified into Class I, IIa, IIb, and III based on risk.
Requirements depend on the product, applicable legislation, and supply chain. This information is provided for general guidance and does not constitute legal advice.
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