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The regulation amendment is crucial for the availability of in-vitro diagnostics, such as HIV tests or hepatitis tests. Most of the in-vitro diagnostics currently available on the market do not comply with the EU regulations in force since May 2022. The new regulation will give manufacturers more time to comply with the requirements depending on the type of product and the associated risk to individuals or public health:
- Products with a high risk to individuals and public health, such as HIV or hepatitis tests (class D), will have a transitional period until December 2027
- Products with high risk to individuals and/or moderate risk to public health, such as cancer tests (Class C), will have a transitional period until December 2028
- Low-risk devices (class B, such as pregnancy tests, and class A sterile devices such as blood collection tubes) – until December 2029, respectively.
Furthermore, manufacturers are required to notify the competent authorities, distributors and healthcare providers six months in advance of any interruption in the supply of the products mentioned above. This is to ensure that there is sufficient time to take measures to guarantee patient care.
The Commission has also taken preparations for a targeted evaluation of medical device legislation, intending to examine the impact on the availability of medical devices. Particular attention will be paid to products with special characteristics, such as medical devices for children, innovative products or products for rare diseases. In the future, the Commission intends to review the costs and administrative burden, particularly for SMEs.
