Following the debates in plenary on 4th April 2017, the European Parliament adopted on 5th April 2017 (635 votes in favour out of a total of 713 voters) the final versions of the Regulations on medical devices (MD) and in vitro diagnostic medical devices (IVDMD).
These Regulations will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union (at the end of May / beginning of June 2017).
Their application will be binding for all the Member States of the European Union without national transposition:
- Three years after the date of entry into force, for the MD Regulation
- Five years after the date of entry in force, for the IVDMD Regulation
The MD Regulation will repeal Directives 93/42/EEC (Medical Devices) and 90/385/EEC (Active implantable medical devices) at the date of application.
The IVDMD Regulation will repeal Directive 98/79/EC (In Vitro Diagnostic Medical Devices) and Decision 2010/227/EU (EUDAMED) at the date of application.
These Regulations introduce major regulatory changes, you should anticipate them as of now!
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.). Do not hesitate to contact us for a personalised analysis of your organisation and your products.