Extensions to the IVDR - what diagnostics manufacturers and suppliers need to know

Updated : Tue, January 25, 2022 @ 10:25 PM

The COVID-19 pandemic has brought tremendous change to the world, impacting human health, disrupting global supply chains, and altering the pace and place of how work gets done. One of the secondary effects has been to complicate the ability of diagnostics manufacturers and their suppliers to meet the timelines for complying with the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, potentially threatening the supply of tests critical for ensuring health.

To ensure that the supply of diagnostic tests remains uninterrupted while also prioritising increased oversight for higher risk tests, the European Commission proposed in October 2021 to extend the timeline for full application of parts of the IVDR and this proposal has now been formally adopted in December 2021. Here’s our take on what diagnostics manufacturers and their suppliers need to know about what's changed.

1. A key goal of the new timelines is to help alleviate the bottleneck caused by the limited number of notified bodies.

One of the biggest changes brought about by the IVDR is the dramatic increase in the number of devices that will need review by a notified body, shifting from fewer than 15% of all IVDs under the previous In Vitro Diagnostics Directive (IVDD) to over 90% of all IVDs under the IVDR. 

The number of qualified notified bodies, however, did not develop in time to meet the expected review workload. There are currently only six notified bodies, which cannot provide the capacity needed to review IVD Technical Files submitted by manufacturers in a way that assures patients and healthcare providers the continuity of supply of existing IVD products.  

The new timelines are designed to safeguard health by preventing removal of already available IVDs whilst also prioritising the highest risk tests for notified body review.

2. The general IVDR date of application remains 26 May 2022.

The IVDR date of application on 26 May 2022 remains the same, and only a few key provisions have extended deadlines. This means that all the regulations around vigilance and market surveillance will apply in full as documented for all devices on the market, whether under the new IVDR or the previous IVDD.

3. No changes are proposed to the date of application for new IVDs.

If you are bringing a new IVD to the European market and that IVD will not receive a CE mark prior to 26 May 2022, you should not expect any changes to your timelines. You will need to meet all the requirements specified by the IVDR as it is currently written.

Why? Extending the timelines for new IVDs will not lead to currently available tests being removed from the market to meet IVDR deadlines.

4. No changes are proposed to the date of application for Class A non-sterile IVD devices.

Why? These devices, which comprise ~20% of IVDs on the market, do not need review by a notified body and are not affected by their limited availability.

5. Some changes proposed for IVD devices with notified body-issued certificates under the IVDD.

IVDs with CE marks issued before 25 May 2017

Most IVD devices that have CE marks issued under the IVDD before 25 May 2017 will remain valid until the period indicated on their certificates. The exception is for certificates issued under the EC Verification procedure (Annex VI to Directive 98/79/EC). Under the new deadlines, these certificates will get an extra year, becoming void on 27 May 2025 instead of 27 May 2024, if not transitioned to the IVDR.  

IVDs with CE marks issued under the EC Verification procedure after 25 May 2017

IVDs that have CE marks issued under the EC Verification procedure (Annex VI to Directive 98/79/EC) after 25 May 2017 may, under the new deadline, renew the certificate before 26 May 2022. In this situation, the certificate would remain valid until 27 May 2025.

6. New grace periods for IVD devices currently on the market that do not require notified body certificates under the IVDD but will under the IVDR.

One of the most impactful timeline changes are for IVD devices that are on the market and do not currently have notified body certificates under the IVDD, but will require them under the IVDR. With the revised timelines, these devices may receive extra time to obtain notified body certificates depending on the class of IVD as follows:

7. New grace period for in-house exemptions.

Another big change under the IVDR is a strict application of in-house testing exemptions. These Europe-based labs were among those most affected by the need to conduct high-volume SARS-CoV-2 testing and, as such, are under consideration for extra time to meet IVDR requirements. The new timelines would give these labs up to 26 May 2024 time to meet most IVDR requirements. The one IVDR requirement that they can have more time to meet—up to 26 May 2028—is the justification that their test fulfils an unmet need.

Conclusion

For diagnostics manufacturers and their suppliers, the combination of IVDR and the COVID-19 pandemic have together brought a number of operational and logistical challenges. Fortunately, the European Commission recognises these challenges and is looking for ways to balance safety and health. With the extended deadlines, some organisations will get extra time to comply with the IVDR, but not every organisation. Therefore, analyse the impact of the revised deadlines on your portfolio and keep an eye out for the latest developments.

Need more information on the IVDR? Visit our IVDR Resource Hub for webinars, a white paper, and other resources.