New guidance documents published by the European Commission

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The date of application of Regulation (EU) 2017/745 on medical devices (MDR) is approaching and the European Commission has issued new and updated guidance documents. Please find below a list of the corresponding papers.

  • Factsheet for Class I Medical Devices – What You Need to Know About Regulation (EU) 2017/745
  • MDCG 2021-5 – Guidance on standardisation for medical devices
  • MDCG 2021-6 – Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation 
  • MDCG 2018-1 Rev.4 – Guidance on BASIC UDI-DI and changes to UDI-DI

Furthermore, please note that the Commission has published the first release of the European Medical Device Nomenclature (EMDN) system. The EMDN codes are based on the Italian CND system. Information can be accessed under the following link:

European Medical Device Nomenclature (EMDN)

The aforementioned documents may either be accessed in our library section or sent upon request.

Source: European Commission

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