The European Commission proposes more than just deadline extensions for In Vitro Diagnostics

On 23 January, the European Commission presented a proposal for a regulation to amend the In Vitro Diagnostic Medical Devices Regulation (IVDR) and the Medical Devices Regulation (MDR).

Similar to the adaptation of the MDR (see News 12/2022), the IVDR is to be adapted to give manufacturers more time for the certification of in vitro diagnostics (IVD). IVDs are tests that use biological samples to determine a person's state of health, such as HIV tests, pregnancy tests or blood glucose meters. 

The proposed extended transitional periods depend on the type of product, in particular the risk class of the IVD. For high-risk IVDs, the transitional periods are to be extended by two and a half years from 26 May 2025 to 31 December 2027. For medium and low-risk IVDs, certification is to apply until 31 December 2028 and 31 December 2029 respectively.

Avoiding bottlenecks

The European Commission justifies the adjustment with impending bottlenecks, particularly for high-risk in vitro diagnostics (class D). According to the European Commission, the extension of the conformity assessment procedures for IVD is intended to "ensure the availability of safe products that are essential for healthcare systems and protect patient care".

Same same, but different

The long title of the proposed regulation already gives it away: this is not merely an extension of the IVD deadline. In addition to extending the transitional periods, the European Commission is proposing two fundamental changes that also affect the MDR. For example, a reporting obligation is to be introduced for manufacturers of Medical Devices and IVDs if they discontinue "critical" products from the market. A reporting obligation should always apply if the discontinuation has or may have serious consequences for the health of patients or public health.

In addition, the introduction of the European Medical Devices Database (EUDAMED) is to be accelerated. According to the current regulations, the use of EUDAMED will only become mandatory once all modules are functioning properly. This is to be changed according to the European Commission's proposal. Fully functional modules will be mandatory from the end of 2025.

The DSV welcomes the proposals

The temporary risk-based extension of the transitional periods for IVDs serves to counteract bottlenecks in the supply of these products. The introduction of a reporting obligation for manufacturers when "critical" products are discontinued from the market is also welcomed. It is important to know which products are at serious risk of discontinuation and the exact reasoning why they are being discontinued from the market. From the German Social Insurance's (DSV) point of view, however, a more precise wording is missing. It is unclear under which conditions "serious harm or risk of serious harm to patients or public health in one or more Member States" is to be assumed. The German Social Insurance (DSV) has submitted corresponding proposals in its Opinion.

The Commission proposal is now being discussed in the European Council and Parliament and is to be dealt with in a so-called urgency procedure - as was the case last year with the extension of the MDR deadline.