There was an industry-wide sigh of relief when the UK recognized the extension to transitional arrangements announced for the EU MDR for manufacturers entering the UK market using the CE mark for market access; however, this has created some confusion in the IVD sector.
I have heard several manufacturers say that IVDs have further extensions, so it seemed a good idea to clarify what we currently know. The first elephant in the room is that the UK has not issued an SI extending the standstill period, and while the industry has been assured this is coming, it looks like it will go down to the wire before it is official. At present, the standstill finishes at the end of June 2023, and it will be a disaster for not just the industry but UK patients if this SI is not completed in time for the standstill to be extended.
Second, there was no extension to the transitional arrangement for IVDs in Regulation (EU) 2023/607. The key change for IVDs was that the sell-off period was removed. This means that at the end of a transitional period, stock in the supply chain can continue to be sold. For example, a reagent already in the distribution chain could continue to be sold until its expiration date. IVDs generally have a short shelf life, providing limited benefit but preventing products from being unnecessarily destroyed. There is more benefit to IVDs without limited shelf lives, such as instrumentation and accessories; however, since these are often class A, they should already meet the IVDR.
For the rest of this article, we assume that the SI publication indicated by MHRA will be enforced on time. To gain market access to the UK during the standstill period, which ends on 30th June 2024 (subject to SI publication), manufacturers can use a valid CE mark or apply a UKCA mark according to the requirements described in UK MDR 2002. Manufacturers must pay attention to IVDD certificate expirations, EU transitional arrangements, as well as the UK standstill arrangements to understand the complete picture.
The diagram below summarizes the highlights.
| 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 |
| EU IVDR | IVDR DoA 26th May 2022 Class A non-sterile must meet IVDR | | | 26th May 2025 End of Class D IVDD to IVDR transition IVDD Certificates issued by Notified Body expire | 26th May 2026 End of Class C IVDD to IVDR transition | 26th May 2026 End of Class B + Class A sterile IVDD to IVDR transition | No sell-off period IVDR applies in full after 26th May 2027 | |
| UK Reg | | SI proposing extension to the standstill period to extend from 2023 to 2024 is still pending! | Proposed UK Regulation comes into force | Additional transition for IVDD certificates issued by a Notified Body when using IVDD for market access | | | | End of additional transition for self-declared IVDs using UKCA mark for market access |
Some examples
- Class A non-sterile devices that do not bear an IVDR CE mark can only be placed on the market with a UKCA mark following the requirements in the UK MDR 2002; at present, these devices would remain self-declared.
- Devices using IVDD certificates for market access, such as Annex II List A or B or self-test devices, can only use this route until 26th May 2025, when this transition ends in the EU for all IVDD certificates; at this point, the notified body certificates are no longer valid.
- This rule also catches class D devices such as an HIV test; if they want to use a UKCA mark during the standstill period, they would have to find a UK Approved Body willing to CE mark under the UKCA to the UK MDR 2002 requirements. They would need to meet the Annex II list A requirements. Approved bodies are also notified bodies and are unlikely to have the bandwidth for a UKCA, which may only be valid until 2029. This increases the imperative for these devices to CE mark under the IVDR as soon as possible to continue to sell in the UK, and it would be unlikely to find a UK-approved body to do this.
- Class C and B devices face a similar choice they have to have a valid CE mark which means meeting the EU IVDR transitional arrangements, or they have to meet the UKCA requirements during the standstill period.
- A rubella test, for example, would need to transition to the IVDR by 26th May 2026 to have a valid CE certificate, or during the standstill period, they would need to find a UK-approved body willing to issue a UKCA certificate under UK MDR 2002 equivalent to IVDD Annex II List B.
- Whilst an HBA1c test which is also a class C but not in Annex II List A or B, or a self-test List B under the UK MDR would be able to self-declare under the UKCA during the standstill period.
After the standstill period, the UK revised regulations will apply. It is expected that there may be some form of recognition or reliance on other regions, such as the EU and possibly the US, but no details are available. It is unclear whether the US is included and whether this would apply only to PMA or all listed FDA devices. They will also need to consider a route for devices that do not hold a CE mark; this is particularly important for the UK domestic market and new devices that don't have approval.
In summary,
- Don't get lulled into a false sense of security; there are no additional extensions for IVD devices based on Regulation (EU) 2023/607.
- The devil is always in the detail, and it depends on what class your device is, what approvals it holds, and when certificates expire.
- It's becoming a catchphrase, Don't take your foot off the gas. Now is not the time, regardless of how tempting this is in the current economic climate.
- International regulations are becoming more interlinked, so it may be prudent to review and revise your regulatory strategy; however, if the UK is a key market for you, then EU recognition is the only region that the UK has specifically recognized to be part of their new regulatory model moving forward so this should be a key part of your logic. Additional benefits of US regulation may be a bonus that can be taken advantage of once the UK's plans are clear, but keep pushing your EU approvals for now. Notified bodies have started to have capacity, especially for class B devices, so Don't take your foot off the gas!
Would you like to know more about the EU-IVDR?
On the 25th of May, Sue Spencer presents the Free Webinar; EU-IVDR one year on! Don't take your foot off the gas!