Regulatory Development in Europe

The two regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in-vitro diagnostics (IVDR) came into force on 25 May 2017. After a 3-year transition period for the MDR (26 May 2020) and a 5-year transition period for the IVDR (26 May 2022), the respective regulations become valid. The date of application has been postponed to 26 May 2021 for provisions of Regulation (EU) 2017/745 that would otherwise apply from 26 May 2020. The corresponding directives will for the most part be repealed on the date of validity of the Regulation - i.e. Directives 90/385/EEC and 93/42/EEC on 26 May 2020 and Directive 98/79/EC on 26 May 2022.

The following corregendums were made to the Regulations:

In April 2020, the Regulation amending Regulation (EU) 2017/745 concerning medical devices as regards the date of application of some of its provisions was published.

With regard to the transitional provisions in the regulations, FAQ documents have been prepared and published by the European authorities:

For the implementation of the MDR and IVDR, a roadmap was developed and published by the European authorities in which work packages for the respective European working groups were formulated.

Further information on the MDR and IVDR is also available on the European Commission's website.

Guidelines (MDCG documents) are being developed at European level for the harmonized implementation of the regulations. The guidelines are published on the website of the European Commission.


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