LSHC Horizons Brochure 2024 - Flipbook - Page 83
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Europe
New European Commission’s proposal amending the MDR and IVDR
In January 2024, the European Commission
(Commission) published a proposal for
a Regulation extending the transitional
periods for certain In Vitro Diagnostics
(IVDs), providing for the gradual roll-out of
the European database on medical devices
(EUDAMED) platform and also laying
down certain information obligations for
manufacturers in case of interruption of supply.
Extension of the transitional periods
for IVDs
Under the proposed Regulation manufacturers
will have additional time to bring their IVDs
into compliance with the IVD Regulation
(IVDR). The new timelines, similar to what is
currently provided in the IVDR, will depend on
the IVDs’ risk class:
• Class D IVDs: transition period until
31 December 2027;
• Class C IVDs: transition period until
31 December 2028;
• Class B IVDs and sterile Class A IVDs:
transition period until 31 December 2029.
As regards “in-house IVDs”, health institutions
will now have until 31 December 2030 (instead
of 26 May 2028) to demonstrate that there
is no alternative and equivalent commercial
device on the market to address the target
patient group's specific needs.
EUDAMED
Under the current rules, the use of EUDAMED
will only be mandatory once all modules are
functional. The proposed Regulation intends to
accelerate the launch of the parts of EUDAMED
that are already finalized, allowing the
mandatory use of several modules as of
late 2025.
Information obligation in case of
interruption of supply of certain medical
devices and IVDs
The proposed Regulation intends to amend
the Medical Devices Regulation (MDR) and
IVDR and include a new article (Article 10a)
requiring that when manufacturers anticipate
an interruption of the supply of a medical
device or IVD and where it is reasonably
foreseeable that this interruption may result
in serious harm or a risk of serious harm to
patients or public health in one or more EU
Member States, manufacturers shall notify the
anticipated interruption (at least six months in
advance) to the competent authority of the EU
Member State where they are located, as well as
to the economic operators, health institutions
and health care professionals (HCPs) to
whom they directly supply the device or IVD.
Economic operators (including importers
and distributors) who have been notified by
the manufacturer shall also inform any other
economic operators, health institutions and
HCPs to whom they directly supply the
device or IVD.
The proposed Regulation will now be put
forward to the European Parliament and
Council for adoption.
Fabien Roy
Partner
Brussels
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