EU Compliance for Medical Devices
Medical devices sold in the EU require CE marking under MDR (EU) 2017/745 or IVDR (EU) 2017/746. Notified body involvement is required for most device classes.
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Medical devices are subject to the EU Medical Devices Regulation (MDR) (EU) 2017/745 or the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. CE marking is mandatory and requires a conformity assessment, clinical evaluation, and technical documentation. Most device classes require notified body involvement. An EU Authorised Representative is specifically required under MDR/IVDR for non-EU manufacturers — this is a distinct legal requirement from the general GPSR EU AR.
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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