LS&HC Horizons 2023 - Flipbook - Page 65
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Europe
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The strategic interplay between EU MDR/IVDR and UK MDR
for medical device launches
Working out the optimal regulatory strategy for
launching a medical device in the UK and EU
requires understanding both the current and
future regulatory requirements in each market.
New medical devices launched in the EU
need to comply with the EU Medical Devices
Regulation (EU) 2017/745 (EU MDR) or In
Vitro Diagnostic Devices Regulation (EU)
2017/746 (EU IVDR), which have applied since
26 May 2021 and 26 May 2022 respectively.
Depending on the classification of the device,
a conformity assessment by a Notified Body
may be required in order to CE mark the
device. Many Notified Bodies are experiencing
capacity issues due to assessing existing devices
transitioning from the previous EU legislation
to the EU MDR/IVDR.
In Great Britain, the UK Medical Devices
Regulations 2002 (UK MDR) still reflect the
previous EU medical device directives. New
devices can currently be launched with a UK
Conformity Assessed (UKCA) mark under the
UK MDR or a CE mark under the EU MDR/
IVDR. The UK MDR will be amended, likely
from 1 July 2024, to align more closely with the
EU MDR/IVDR though some divergence
in requirements will remain.
Fabien Roy
Partner, Brussels
These different regulatory requirements
and timings impact the optimal regulatory
approach, including whether to CE mark
only or whether an earlier launch may be
possible by UKCA marking under the UK MDR.
The answer depends on variables such as:
• How long the manufacturer needs to compile
the necessary technical documentation
for the UK MDR versus EU MDR/IVDR;
• The classification of the device, particularly
whether it can be self-assessed or requires
the involvement of a Notified Body –
for example, many software devices are
currently self-assessed Class I devices under
the UK MDR and Class IIa under the EU
MDR requiring a Notified Body;
• Notified Body availability for the type
of assessment required.
Working through the above for the specific
device in question is key to optimizing any
EU/UK launch strategy.
Jane Summerfield
Partner, London