IVD News – Progressive Roll-Out and MDCG 2022-2 on Clinical Evidence

“There is no time to rest”, was the merciless verdict of Stella Kyriakides, Commissioner for Health and Food Safety, in the European Commission’s press announcement on the Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation (IVDR).

For anyone involved in IVDR transition activities it is hard to disagree with the commissioner’s outlook. For manufacturers, economic operators, notified bodies, legislators, and healthcare providers alike, the amended transitional provisions of the IVDR represent much more a last lifeline than a holiday cruise ticket.

The roll-out announces extended transitional periods for devices for which a declaration of conformity has been drawn up prior to 26 May 2022 in accordance with the IVD Directive devices (IVDD), and for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body. In short, currently IVDD compliant devices that will be classified as A sterlie, B, C or D devices under IVDR may be placed on the market until:

• 26 May 2025 for class D,
• 26 May 2026 for class C,
• 26 May 2027 for class B,
• 26 May 2027 for class A sterile,

provided that the devices continue to comply with the IVDD and do not undergo significant changes. In addition, the requirements of IVDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to those devices, instead of the corresponding requirements of the IVDD.

Now, what is a significant change? And exactly which articles of IVDR must be complied with starting May 26th? The IVD community is missing much of the guidance documents available for the Medical Device Regulation (MDR) to help interpret the transitional provisions. But we may still leverage the information available for the corresponding transitional rules of the MDR, assuming the interpretation for IVDs should not significantly differ. Our tips here:

• MDCG 2020-2 rev.1 Class I transitional provisions under Article 120 (3 and 4) – (MDR)
• MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
• MDCG 2021-25 Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
• MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

Useful guidance is also provided in the FAQ documents published by Competent Authorities for Medical Devices (CAMD) in 2018 on the transitional provisions of the MDR and of the IVDR. Here one may, for example, find the exact paragraphs to look out for in the IVDR regarding obligations to be met by devices benefiting from the transitional period:

• Registration of economic operators and of devices: Art. 28 IVDR and Art. 26 IVDR
• Post market surveillance (PMS): Art. 78-81, 87 IVDR including Annex III but without the PMS having to be an integral part of the QMS
• Market surveillance: Art. 88 – 95 IVDR, but device standards to be met = Directives
• Vigilance: Art- 82-87 IVDR

If your devices benefit from the progressive roll-out of the IVDR, now is a good time to have a closer look into those guidance documents and into the IVDR articles that will apply to your legacy device in three months’ time. Make sure to remain compliant and get the most out of the transitional period by updating your quality management system and the technical files in the above-mentioned areas.

Let us not forget those who were left without a lifeline. Devices that fall into the risk class A must comply with IVDR from 26.5.2022, as must any IVD device that will be placed on the market for the first time after 26.5.2022 and does not have a declaration of conformity according to IVDD.  A helping hand was recently offered to those on the last countdown to IVDR compliance, who are finalizing their performance evaluation reports and post market performance evaluation plans;  the new guidance document MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) repeats a lot of what we know from the regulation (scientific validity + analytical performance + clinical performance, remember?) but does provide concrete new insights such as elements to consider in the intended use statement, examples of analytical performance indicators and potential sources of clinical performance data.

In the meantime, another tidal wave is approaching in Switzerland, where the update of the In vitro Diagnostic Devices ordinance is in progress and no Mutual Recognition Agreement of the IVDR with the EU is in sight. We expect a similar third-country structure already in place for medical devices, with significant impact on the rules for both import to and export from Switzerland. Stay tuned for our updates on Switzerland on the IVD blog series.

Whatever challenge you are currently tackling on the IVD front, confinis experienced and dedicated in-vitro diagnostic medical device experts can help you with all steps of IVDR implementation and certification of your devices. We leverage our longstanding experience with IVDs as well as many successful MDR transition projects to provide you with the best and most efficient solutions for quality and compliance. You can focus on your core work, take a rest when you need to, and rely on us to get the job done.