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The Medical and In Vitro Diagnostic Medical Devices regulations (MDR and IVDR) have been published on May 5th, 2017 in the Official Journal.

Both regulations are available on the website of EUR-lex:

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

The date of entry into force for the new regulations on Medical and In Vitro Diagnostic Medical Devices (MDR and IVDR) is May 25th, 2017.

The transitional period will officially start right after the entry into force.

The transition to the EU Medical Device Regulation (MDR) will last 3 years; with 2020 as the application date. The In Vitro Diagnostic Regulation (IVDR) will have a longer transition period, set to last 5 years with 2022 as the date of application.

MDSAP Prepare the transition, worldwide market access

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