Agreement reached on Europe’s medical device and IVD regulations

By Ronald Boumans, Emergo Group

European regulators and lawmakers have agreed on long-awaited new regulations covering medical an in vitro diagnostic devices in one of the world’s largest markets.

On 25 May 2016 the European Parliament  and the European Council jointly announced that an agreement has been reached about the Regulations for Medical Devices and In-Vitro Diagnostics.

Emergo consultants in The Hague have learned that the First Reading Drafts will be published mid-June and the Regulations will be adopted in the autumn of 2016. There will be a three-year transition period for medical devices and a five-year transition for IVDs.

This means that manufacturers whose devices are CE Marked for sale in the European Union will have until autumn of 2019 to get ready for the medical device regulations and until autumn of 2021 for IVD regulations.

We will keep you informed once the drafts have been publicized. For in-depth analysis of the ongoing European regulatory overhaul, download our MDR whitepaper.

Previous Emergo blog coverage of European medical device and IVD regulatory changes can be found below:

• New European Medical Device Regulation taking next step forward in June?
• Dark Clouds over Europe?
• The Future of Eudamed—Better, Bigger, Riskier
• News from Europe: Trilogues, Medical Devices and IVD Regulations Carry on in 2016

Ronald Boumans is Senior Global Regulatory Consultant at Emergo’s office in The Netherlands, and a former senior inspector at the Dutch Healthcare Inspectorate.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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