Regulation (EU) 2022/112 – IVDR Transition Proposal in EU Approved and “set in stone” by the European Parliament
“Set in stone” by the European Parliament
On the 25 January 2022, Regulation (EU) 2022/112, amending the transition provisions to Regulation 2017/746 (IVDR) was published by the European Union. The industry was alive to the sounds of a potential “delay” in October 2021, where a proposal for an amendment to the full adoption of IVDR by 26 May 2022 was put forward. This proposal was very quickly followed by a very fast and expedited review and decision through the European Council (01 December 2021) and then confirmed by the European Parliament (16 December 2021), with no amendments.
It’s been well documented that the proposed amendments are due to the COVID-19 pandemic and the subsequent diversion of global resources across the IVD industry AND the limited number of Notified Bodies that are designated to IVDR. But, now that it is “set in stone”, where does this leave manufacturers and what does and doesn’t have to be done by the 26 May 2022?
The word “delay” is regularly used to describe this change; however, it is not strictly correct. The IVDR will still become the legislative framework for IVDs in the EU from original the date of application (DOA), 26 May 2022 and significant parts of the IVDR will need to be fulfilled by IVD manufacturers from that date;
- Low risk Class A products must comply with the IVDR in full by May 2022
- The extended transition dates are dependent on a device’s classification under the implementing rules in Annex VIII. This means that manufacturers will need to update their internal processes, in order to carry out this assessment and update their technical file documentation to reflect the new device classification.
- Post Market Surveillance, according to Chapter VII, Annex III and Annex XIII part B, will need to be carried out by all IVD manufacturers, from May 2022 on all products.
- Registration requirements according to Articles 26, 27 and 28 of the IVDR will apply from May 2022
The main difference now, however, is that the transition to full compliance to IVDR is dependent on the device’s classification within the IVDR. The highest risk devices, Class D devices, now have until May 2025 to transition, Class C devices until May 2026 and Class B and Class A sterile devices have until May 2027. Though, and this is important, this only applies if the product is already on the market with a CE mark prior to the DOA and only if there are no significant changes to the product
If the product is new and placed on the EU market after the DOA, or a significant change is made to a current CE marked product after the DOA, these will need to go through Notified Body review.
What have we learned?
The approval of the proposed transition extension is good news for an IVD industry that has been hit hard by significant regulation changes and the COVID-19 pandemic. It is good news for patient’s access to testing too. It remains to be seen whether this is enough and whether this extension will be used wisely by all involved. What is clear is that there is an opportunity for manufacturers to act now and to be prepared and ensure that products remain on the market.
So, this is not time to rest and wait. Part of the reason the industry is not ready for the original deadline, is that manufacturers did not take full advantage of the 5-year transition period, and despite the acknowledged problematical factors, the industry should not make the same mistake again! Transition to IVDR is a significant piece of work and should not be left until the last 12 months, when expert resource will be stretched and at a premium!
You honestly can’t plan this too far in advance – and if you need help prioritising or with staff training on the new rules, just get in touch with us on 01295 274286 or via email at firstname.lastname@example.org
Director of Consulting Services