New EU Regulations: Further Details on Designation of Notified Bodies
In May 2017 two new EU Regulations, Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on in-vitro
diagnostics, entered into force. From 26 November 2017
, notified bodies can submit applications to be designated under these new Regulations.
Until the date of full application of the new Regulations, 26 May 2020 for medical devices and 26 May 2022 for IVDs, devices can continue to be certified and placed on the market according to the current Directives. Alternatively manufactures can, on a voluntary basis, certify their devices to the new Regulations ahead of the date of full application.
Notified Body Requirements under the New Regulations
Both Regulations significantly increase the requirements which must be fulfilled before being designated as a notified body under the new Regulations.
These new requirements are set out in Annex VII and are divided into four categories:
- organisational and general requirements,
- quality management requirements,
- resource requirements;
- process requirements.
Timeline for Designation to the MDR
The designation process under the new Regulations is expected to take up to 18 months after which notified bodies can begin to certify devices to the new Regulations. It is anticipated that the first MDR designated notified bodies will be able to begin assessing and certifying devices to the MDR by mid-2019.