Posted 23 February 2017
By Michael Mezher
Device manufacturers looking to abide by the EU's new medical device and in vitro diagnostic regulations take note: The EU's overhaul of its framework is here.
On Wednesday, the European Council released the final texts of its long-awaited Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR), with voting on the texts set to begin in March.
The effort, which began in 2012, has been plagued by delays as the legislation made its way between the European Commission, European Parliament and European Council.
According to an EU official, "The content of the two regulations on medical devices and in vitro diagnostic medical devices is still the same as in the agreement reached between the Council of the EU and the European Parliament in May 2016 which has been approved by the Council on 20 September 2016 … The difference between these 'old' documents and the 'new' documents is that the new documents have undergone a legal-linguistic review to make sure that the texts are coherent and equivalent in all 24 official EU languages. So in other words: the wording might have changed, but apart from corrections of some obvious mistakes and addition of necessary clarifications the new EU rules remain unchanged.
Now that the legislative texts have been finalized, the European Council is scheduled to hold a vote to adopt the legislation on 7 March 2017, followed by a vote in the European Parliament in April.
If passed, the regulations could be formally published by May 2017, and enter into force in either May or June. Given that timetable, the new rules established under the MDR would apply in 2020 and the IVDR regulations would apply in 2022.
Weighing in at 566 and 477 pages, the two documents will upend the EU's existing regulatory framework for devices and IVDs, with an emphasis on ensuring safety and effectiveness for those products after scandals involving metal-on-metal hip implants and faulty breast implants exposed weaknesses in the EU's existing framework.
Medical Device Regulations – Final Text
In Vitro Diagnostics Regulations – Final Text
Draft Statement of the Council's Reasons – Medical Devices
Draft Statement of the Council's Reasons – In Vitro Diagnostics