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 were permitted to submit applications to be designated under these new Regulations.
Until the date of full application of the new Regulations, 26 May 2021 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 duration of the designation and notification processes under the new Regulations can vary depending on the quality of the application and the timeliness of resolution of issues encountered during the review and on-site assessment phases. Initial designations completed under MDR and IVDR took longer to complete than expected for a number of reasons including the new learning curve and diverging opinions between stakeholders at the onset of applying the new Regulations. At this time, the overall process can take up to 18 months to complete.
Under the MDR / IVDR, a complete re-assessment of the notified body is required three years after initial notification and every fourth year thereafter.