On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations. The agreement seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had not been updated since 2007.
The regulations will strengthen the rules for placing medical devices on the market, as well as tighten market surveillance and vigilance. The regulations seem to take the step of establishing requirements for high-risk device expert reviews, and the regulations set forth specific duties for all economic operators, including manufacturers and distributors.
Following the regulations’ entry into force, or official publication, the medical device regulations will have a three-year grace period (five years for IVDs) before they are fully applicable and enforced. There will be interim enforcement periods for some requirements. Medical device and IVD manufacturers should carefully read the final regulations when they are published to adequately build a plan to comply with the new regulations.
The EU Council’s Permanent Representative Committee will be invited to endorse the agreement mid-June 2016, after which the EU Parliament’s Committee on Environment, Public Health, and Food Safety (“ENVI”) will also be invited to endorse the agreement. After the texts are fully revised and in their final form, the texts will be formally adopted by the EU Council and Parliament.