a&r has good news for manufacturers of medical devices in the area of public healthcare products. The transition period of the In Vitro Diagnostic Medical Device Regulation (IVDR) will probably be prolonged for certain in vitro diagnostics (IVD).
On 14 October, the European Commission (EC) proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation. Subject to adaption of the proposed amendment by the European Parliament and Council, the following changes will apply:
Firstly, the transition period for current IVDs with a Notified Body certificate will be prolonged by 1 year until 26 May 2025. Furthermore, the following timelines apply for current IVDs with a conformity assessment without a Notified Body, which will require a Notified Body under the IVDR:
- for class D devices 26 May 2025;
- for class C devices 26 May 2026;
- for class B devices 26 May 2027;
- for sterile class A devices 26 May 2027.
However, the general publication date of the IVDR will remain 26 May 2022. Therefore, all new IVDs need to comply with the IVDR as of that time. All current IVDs that do not require a Notified Body under the IVDR (applies for non-sterile class A devices) need to comply with the IVDR simultaneously from May 26, 2022.
If you need assistance with your medical devices and the legal requirements under the new IVDR, please get in touch with us.