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:

• Clear obligations for manufacturers, importers, and distributors such as traceability of devices, registration of devices, verification of labelling, etc.
• Revision of the classification system to 4 risk classes:
  • Class A: Low individual risk and low public health risk.
  • Class B: Moderate individual risk and/or low public health risk.
  • Class C: high individual risk and/or moderate public health risk.
  • Class D: high individual risk and high public health risk.
• More stringent control for high-risk IVD devices with the introduction of a new pre-market review mechanism at the EU level.
• Reinforcement of the criteria for the designation and oversight of notified bodies. Currently, only 8% of the IVD devices on the market are subject to a notified body’s control, the new IVD Regulation boosts this number to 80%.
• Improvement of transparency with a publicly accessible medical device database (EUDAMED).
• Introduction of a traceability system via unique device identifiers (UDI).
• Strengthening rules on clinical evidence and performance evaluation such as an EU-wide coordinated procedure for authorizing multi-center performance studies.
• Fortify post-market surveillance requirements for manufacturers.
• Improve coordination between EU countries on vigilance and market surveillance.
• Adopt a specific regime for in-house devices (devices manufactured and used within the same health institution).

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:

• Higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (Class C) have a transition period until May 2025 and 2026.
• Lower risk devices such as class B and A sterile devices have a transition period until May 2027.
• Despite the revised transitional provisions, the IVD Regulation will become effective on May 26, 2022. Therefore, devices that do not involve a notified body (i.e. Class A non-sterile devices) are required to comply with the new IVD Regulation in full by May 26, 2022. Devices that are addressed by the transitional periods must continue to comply with the current Directive and should not introduce significant changes in the design and/or intended purpose. Please note that the reinforced rules on vigilance and market surveillance are effective on May 26, 2022, and will apply to all types of medical devices.

If you would like to learn more about the IVD Regulations or how it would affect your business or organization, contact us today.