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Publication of the Regulations on medical devices and in vitro diagnostic medical devices

Are you ready for change? We have finally got there... The Regulations on medical devices and in vitro diagnostic medical devices were published on 5th May, 2017 in the Official Journal of the European Union.

We can now put a name (and finally ... a number) to these texts:

Regulation (EU) 2017/745 on MD
Regulation (EU) 2017/746 on IVDMD    

In 20 days, i.e on 26th may 2017, these Regulations will come into force. Their application will be binding :

·      after a three year transitional period for the MD Regulation, i.e. from 26th may 2020

·      after a five year transition period for the IVDMD Regulation, i.e. from 26th may 2022

Do not wait until the last moment to comply : these Regulations introduce major regulatory changes that you should anticipate as of now!

Time-consuming ? That is the right word

But do not worry! Nexialist has analyzed the regulatory impacts for all economic operators in the MD and IVDMD sectors (manufacturers, authorised representative, importers, distributors, notified bodies, competent authorities, etc.).

This represents more than 5 years of preparation, and over 1300 hours of analysis over the last six months.
We now know what these texts have to offer ... but we are not immune to surprises as to their interpretation!

Do not hesitate to contact us for a personalised analysis of your organisation and your products.