1st August 2023 UK Government announces indefinite extension to CE marking > Read More...
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Summary

Medical devices in Europe are regulated under the European Medical Device Regulations (EU 2017/745) which have applied since May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. The EU MDR repealed Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices and changed the European legal framework for medical devices, introducing new responsibilities for national competent authorities in the assessment of certain categories of medical device. Prior to placing a device on the market in the EU, a manufacturer is required to ensure it meets the requirements of the Regulation’s Unique Identification rules, and is included on the UDI database. If located outside of the EU, a manufacturer will need to engage the services of an Authorised Representative with physical presence in the EU, who will take care of regulatory issues on the ground in the EU. Other Regulations exist for other categories, such as:

  • In Vitro Diagnostic Medical Devices, covered by EU 2017/746
  • Cosmetics, covered by EU 1223/2009
  • Medicinal Products, covered by Directive 2001/83/EC (or by 1394/2007 for advanced therapies)

 

See our new Medical Devices Directive page for Great Britain

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