In vitro diagnostic medical devices contain a broad spectrum of devices that test biological samples to determine the status of one’s health, from self-tests for pregnancy, to blood glucose tests for diabetes, to tests for HIV or COVID-19, and many more. The In Vitro Diagnostic Medical Device Regulations (IVD Regulation) came into force in May 2017 and was set to become effective on May 26, 2022, to replace current Directive 98/79/EC on in vitro diagnostic medical devices. This IVD Regulation ensures high-level protection of public health, patient safety, and smooth operation of the internal market.
The regulatory framework for regulating medical devices in the market in the European Union (EU) was created in the 1990s. To reflect the advancements, changes, and technological and scientific progress in medical devices, the rules and regulations are being updated to modernize and consolidate the sector:
The new rules contain the following changes:
However, due to the outbreak of COVID-19, the implementation of the substantial changes as outlined in the IVD Regulations cannot be completed by May 26, 2022; especially with the shortage in notified body’s capacity. It is also hard for manufacturers to conduct the required conformity assessment in time. Therefore, to avoid disruption in the supply of medical devices, the transitional period as mentioned in Article 110 of the IVD Regulations has now been extended to May 26, 2025, for IVD medical devices with a certificate issued prior to May 26, 2022 (only applicable to those devices that require a certificate from the notified body).
On October 14, 2021, the European Commission (EC) proposed a progressive roll-out of the new In Vitro Diagnostic (IVD) Medical Devices Regulations to prevent disruption in the supply of essential healthcare products during the COVID-19 pandemic. As per Stella Kyriakides, the Commissioner for Health and Food Safety, shortages of medical devices are composed of unprecedented challenges, and ensuring a continuous supply of in vitro diagnostic medical devices, while not compromising the safety of these products, is essential and critical at this point of time. Manufacturers are encouraged to prepare for certification under the new Regulations as soon as possible and should not wait until the end of the transition period.
The proposal does not alter the requirements of the IVD Regulations in substance but introduces changes to the transitional provisions to allow progressive roll-out of the Regulations. The length of the proposed transition periods is based on the risk and type of the device:
If you would like to learn more about the IVD Regulations or how it would affect your business or organization, contact us today.