The European Council has 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.
Now that the legislative texts have been finalized, the European Council is scheduled to hold a vote to pass the legislation on 7 March 2017, followed by a vote in the European Parliament on 20 March 2017.
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