EU Parliament set to OK MDR deadline delay for some Class I devices

Dive Brief: The European Parliament plenary session is slated to adopt language that would push […]

Dive Brief:

  • The European Parliament plenary session is slated to adopt language that would push back the Medical Device Regulation compliance deadline for certain Class I medical devices by four years.
  • Unless enough lawmakers request a vote, the so-called corrigendum is set to be automatically adopted at 11:30 a.m. EST Tuesday, according to European Parliament press officer Thomas Haahr.
  • The extension, if adopted, applies to certain Class I devices that would be required to undergo review by a notified body for the first time.

Dive Insight:

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 appears 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.
It appears no political group has sought a vote to be held as of Tuesday morning EST, according to Haahr.
A last minute bid could still happen, but seems unlikely given the lack of controversy.
“If a vote has been requested by a political group the corrigendas should be added to the plenary agenda tonight or tomorrow morning,” Haahr told MedTech Dive in an email.
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.

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