A European Parliament committee Tuesday voted to adopt changes to the EU Medical Device Regulation that would push back the compliance deadline for certain Class I medical devices by four years.
While expected, the extension would be another respite for industry bracing for the law’s looming start date next May
The changes adopted by the Committee on the Environment, Public Health and Food Safety still need to be cleared by the full Parliament, although a vote will only be required if the political groups, including the European Council and member states, request it. If there’s no such request, the changes will be considered approved during the plenary session set to run Dec. 16 through Dec. 19.
“If there is agreement, the hope is that they could finalize the process by this month,” an EC spokesperson told MedTech Dive in an email.
The extension would apply to current Class I devices that require notified body review under the MDR and that are not otherwise afforded an additional transition period under the regulation.