Sundhedsudvalget 2022-23 (2. samling)
SUU Alm.del Bilag 7
Offentligt
Professor Vlastimil Válek
Deputy Prime Minister and Minister of Health
Palackého náměstí 4
128 01 Praha 2
Czechia
Brussels, 26 October 2022
Re: Implementation of the EU Medical Device Regulation 745/2017 (MDR) – Urgent Need for
Legislative Action
Dear Deputy Prime Minister Válek,
As industry leaders of the medical technology industry, we would like to reiterate our serious concerns
regarding the current implementation status of the Medical Devices Regulation 2017/745 (MDR).
Unless immediate action is taken, Europe faces a scenario where a high number of existing medical
devices, upon which patients, hospitals and other health institutions rely, will fail to be re-certified on
time and therefore risk to permanently disappear from the market. At the same time, certification of new
and improved products is also delayed, resulting in delayed patient access to the benefits of innovation.
We therefore call upon you to urgently support and introduce measures of
legislative nature
(i.e.,
via formal amendment of the MDR) to safeguard the continuity of patient care across Europe and
the world.
After more than five years of implementation, the MDR regulatory system still lacks sufficient certification
capacity needed to certify
1) Existing devices that have been on the market for years and that are required to undergo re-
certification under the Regulation by no later than 26 May 2024 and
2) New or significantly changed devices.
There are around 25,000 certifications under the former Medical Devices Directives covering hundreds
of thousands of existing devices. As of today, only a small fraction of these former certifications has
been replaced with the needed MDR certifications. To make things worse, more and more of these
former certifications are expiring, with two thousand expiring now in 2022, double that amount in 2023,
and
more
than
seventeen
thousand
expiring
in
the
first
four
months
of
2024.
The ongoing COVID-19 pandemic and the war in Ukraine have exacerbated this situation by creating
supply chain disruptions, issues with conducting on-site audits and with clinical investigations.
Since the EU Employment, Social Policy, Health and Consumer Affairs Council meeting of June 2022,
national regulatory authorities in the Medical Devices Coordination Group have proposed 19 (non-
legislative) measures via the paper MDCG 2022-14, which are designed to free up some Notified Body
capacity.