Progressive rollout of the In Vitro Diagnostic Medical Devices Regulation

Thanks to the adoption of the European Parliament and Council, the In Vitro Diagnostic Medical Devices Regulation, which will be in effect from 26 May 2022, can now gradually be implemented. 

Health institutions and economic operators redirected financial and other resources in the context of the COVID-19 crisis to meet the unprecedented challenges. They delayed the implementation of In Vitro Medical Devices Regulation 2017, which established certain requirements for medical equipment and gave greater authority to so-called conformity evaluation bodies. In October, the Commission proposed a progressive rollout of the Regulation of 2017 to prevent disruptions in the supply of essential healthcare products. The co-legislators will adopt this proposal to keep these essential healthcare products in supply. 

Stella Kyriakides, Commissioner for Health and Food Safety, welcomed the adoption. She stated: "In the face of an unprecedented public healthcare crisis, we cannot risk a shortage of essential medical devices. The health systems and routine services of the NHS have been thoroughly tested. This pandemic has also highlighted the need for reliable diagnostics and a robust regulatory framework for in vitro medicinal devices. Amendments to the In Vitro Diagnostic Medical Devices Regulation are necessary to ensure that vital medical devices such as HIV or COVID remain safe and available. Manufacturers, notified bodies, Member States and manufacturers will now have to take extra time to build the required capacities. Manufacturers must also prepare for the transition to the new requirements. There is no time for rest.

Next steps 

The amendment Regulation does not alter any requirements of the original In Vitro Diagnostic (IVD) Regulation from 2017. This amending Regulation only changes certain requirements regarding medical devices' application dates. 

The new requirements for higher-risk devices such as HIV and hepatitis (class D) will be in effect as of May 2025. Lower risk devices, such as influenza tests, are extended to May 2026. However, applications for lower-risk devices (class B or A sterile) will open in May 2027. 

Applying some requirements to devices manufactured in the same hospital (so-called "in-house devices") is delayed by two more years, until May 2024. The transitional periods will be shortened if the health institutions can prove that an equivalent device is not available on the market. 

Background 

The 2017 IVD Regulation introduced significant changes to the regulatory framework for in-vitro diagnostic medical gadgets, such as HIV and pregnancy tests or SARS/CoV-2 tests. The role of conformity assessment bodies, also known as 'notified bodies', will be more significant. They will independently verify that devices meet safety and performance requirements before entering the EU market. 

The IVD Regulation will be effective as planned from 26 May 2022. The problem is that there is not enough capacity for notified bodies to perform the conformity assessment procedures required by law. There was a danger of serious disruption to the supply of essential in vitro diagnostic medical equipment on the market. This could affect the diagnosis of patients and their access to appropriate health care. 

There is no proposal to amend CE-marked devices, which do not require the involvement of notified bodies under the IVD Regulation, and new devices'. Devices without a notified-body certificate or a declaration of conformity as per the current Directive 98/79/EC. The IVD Regulation will cover these devices, effective 26 May 2022. 

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