The clock is ticking

European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) are now published.

The transition periods have started, including ISO 13485:2016.

So, May 5, 2017, was the big day when the two regulations were listed in the Official Journal of the European Union (OJEU).

And we were already aware that entry into force would occur 20 days later. So, on May 25, 2017,  both regulations entered into force and this saw the start of the transition periods. For the MDR it is three years and for the IVDR it is five years.

On May 26, 2020, the transition period for the MDR will end and on May 26, 2022, the transition period for the IVDR will end. Medical device companies will become more familiar with these dates as they develop their own transition plans.

Closely linked to the regulations is the International Standard for Quality Management Systems ISO 13485:2016, which is also part-way through its own transition period and this will end on February 28, 2019.

The organisation (Certification Agency) which grants your certificate will likely cease to issue certificates to the previous version of the standard sometime during 2018.

For now, be mindful of the transition periods as you begin to think about all the issues and challenges.

Work closely with your Certification Agency/Notified Body, think about some form of training /learning/staff awareness related to the content of the Regulations or any particular aspect that relates to your devices.

The 28 members of the Council of the EU unanimously voted to adopt the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR).

The new rules introduce deep changes in the regulatory framework for the marketing of devices and IVDs in Europe, the world’s second-largest device market.