The EU Commission published that EU Parliament and Council have adopted the proposed amendment to the IVDR, to push out application dates for most (though not all) IVDs.
What does this mean exactly?
The press release reiterates that this is not a delay of the IVDR, per se. Instead, it’s a staggered delay to the compliance for some IVDs. Specifically, those IVDs that now require Notified Body certification under the IVDR. This is an important distinction because there is a severe lack of notified bodies accredited to the IVDR and a huge number of products that need certification.
Devices that do not require Notified Body CE Marking under the IVDR (i.e., Class A non-sterile, self-certified devices) must still comply with the IVDR on its date of application: 26 May 2022. As well, any IVDs newly entering the market as of 26 May 2022 also require IVDR CE Marking.
Why was this needed?
The EU Commission’s original proposal indicates that while around 3,300 IVDs (~8% of all IVDs on the market) require notified body involvement under the IVDD, the number rises to 24,000 (~78%) under the IVDR – a 725% increase.
Meanwhile, there are six designated notified bodies* as of this writing. Compare this to the 22 notified bodies that were designated under the IVDD for those 3,300 CE marked products and you see the problem.
The proposal also states while there are 1,545 CE Certificates issued under the IVDD, only 31 CE Certificates have been issued under the IVDR, with 520 applications pending. I.e., 95% of the products that require a notified body involvement, do not have IVDR CE Marking certificates issued. With only six months to the IVDR date of application, Europe would lose access to virtually all IVD products.
The above would have included the potential loss of COVID tests. Currently these are self-certified under the IVDD. However, they will require Notified Body issued CE marking under the IVDR, generally as Class D devices (highest risk). In the proposal linked above, the EU Commission indicates that no IVDR Class D devices had received CE marking as of mid-October 2021. This would mean zero COVID tests could be placed onto the EU market after 26 May 2022. Now, with the progressive rollout, manufacturers of COVID tests have until 2025 to obtain Notified Body issued CE marking certification.
What are the new IVDR compliance dates?
The rollout staggers the compliance dates, providing some breathing room to handle the high volume of work over the next five years.
- Class A non-sterile (‘self-certified’) – no change, must comply with the IVDR on its date of application, 26 May 2022
- Class A sterile – compliance date of 26 May 2027
- Class B – compliance date of 26 May 2027
- Class C – compliance date of 26 May 2026
- Class D – compliance date of 26 May 2025
*BSI Group The Netherlands B.V., Dekra Certification B.V., DEKRA Certification GmbH, GMED SAS, TUV Rheinland LGA Products GmbH and TUV SUD Product Service GmbH