UPDATE: Dec. 17, 2019: This story has been updated to reflect that the four-year delay is finalized.
- The European Parliament plenary session Tuesday cleared language that pushes back the Medical Device Regulation compliance deadline for certain Class I medical devices by four years.
- Lawmakers did not request a vote on the corrigendum that was adopted by the Committee on the Environment, Public Health and Food Safety in early December, meaning the change became official Tuesday.
- The extension applies to certain Class I devices that would be required to undergo review by a notified body for the first time.
The industry, including trade group MedTech Europe, has been warning about a lack of notified bodies to support the transition to MDR without major disruptions. To date, only eight notified bodies have gained MDR designation.
On Saturday, Dekra Netherlands became designated, but it does not appear the system is on track to have 20 notified bodies MDR designated by the end of 2020 like the European Commission hoped.
The MDR delay for certain Class I devices appeared to be an uncontentious topic at the plenary session. The objective is to lessen pressure on notified bodies by decreasing the number of these lower risk devices they will have to review before MDR goes into effect in May 2020.
According to an email from European Parliament press officer Thomas Haahr Tuesday morning EST, it appeared no political group had sought a vote to be held as of Tuesday morning EST, and a last minute bid seemed unlikely given lack of controversy.
The rules overhaul, which beefs up pre- and postmarket safety requirements and oversight, came amid concern that the patchwork of European country regulatory systems let safety issues fall through the cracks.