Adaptations for Medical Devices and In Vitro Diagnostics
The European Commission proposes more than just deadline extensions for In Vitro Diagnostics
CC – 02/2024
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.