EMERGO SUMMARY OF KEY POINTS:

• The European Medical Device Regulations (MDR 2017/745) and In Vitro Diagnostic Regulations (IVDR 2017/746) have been entered into force as of May 26, 2017.
• The Regulations’ entry into force is the last milestone before full implementation of the MDR in May 2020 and the IVDR in May 2022.

The May 26, 2017 date for official entry into force of new European medical device and IVD regulations has been reached, paving the way for full implementation of these regulations in 2020 and 2022.

The Medical Device Regulations’ (MDR 2017/745) and In Vitro Diagnostic Regulations’ (IVDR 2017/746) entry into force follows their official publication in early May 2017 in the Official Journal of the European Union (OJEU).

Now the official three-year countdown to the MDR’s date of application (full implementation)—May 26, 2020—has begun. By that date, medical device manufacturers active in Europe will have to be fully compliant with the MDR. The five-year countdown to the IVDR’s date of application (May 26, 2022) has also begun.

In the shorter term, European Notified Bodies may begin applying for designation under the MDR and IVDR starting November 26, 2017.

Stay tuned to Emergo’s QA/RA blog for ongoing coverage and analysis of European medical device regulatory developments.

Additional European MDR and IVDR resources:

• CE Mark certification support for medical device companies
• CE Mark certification support for IVD companies
• Whitepaper: MDR timelines and strategies
• Whitepaper: Understanding the European MDR
• Whitepaper: Understanding the European IVDR