Medical Design Briefs - September 2021 - 35

■ Filling in the Gaps
Medical device manufacturers are no
strangers to managing regulatory changes;
for the past few years, companies with
devices in the EU market have been working
hard to achieve conformity with the
requirements of the EU Medical Device
Regulation 2017/745 (MDR) and In Vitro
Diagnostic Regulation 2017/746 (IVDR).
With the UK exiting the EU, however,
manufacturers wishing to remain in the
UK market will need to comply with the
UK Medical Devices Regulations (UK
MDR) 2002 as amended and for access to
the Northern Irish market, the EU MDR
and IVDR. The UK MDR 2002 is based on
the three outgoing EU directives for medical
devices and in vitro diagnostic medical
devices, but it is likely that future UK legislation
will come to closely resemble the
EU MDR and IVDR.
It follows that manufacturers wishing
to make the most of their efforts so far
and avoid any duplication of activity
should thoroughly assess any gaps in
data and documentation and plan strategically
around these, ensuring they
repurpose efforts and resources invested
into complying with EU MDR and IVDR
for UKCA marking wherever possible.
■ Taking a Product-by-Product
Approach
Every time a product is taken through
compliance assessments, it's critical to
make a firm evaluation of how valuable
the product is within the specific market
and to set this against the cost of achieving
compliance to keep it there. Manu -
facturers are advised to assess the compliance
risk of products based on device
classification, CE mark status, UK re -
gional sales, and level of preparedness.
On this solid basis, manufacturers must
consider whether it makes commercial
sense to continue to supply all product
classes to the UK or not. This approach
may also reveal that introducing new
products to the UK market is more costeffective
than previously thought, making
the exercise worthwhile for most
manufacturers.
■ Building a Network of Partners
A new regulatory framework also
requires a new set of actors and responsible
parties. Instead of an EU Authorized
Representative, for example, non-UK
manufacturers must have a UK-based
Responsible Person (UKRP) with a registered
place of business in the UK to continue
trading in the UK. One of the key
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responsibilities of the UKRP is to complete
device registration with the Medicines and
Healthcare products Regulatory Agency
(MHRA) on behalf of the device manufacturer.
The name of the UKRP will also
need to be included on future labeling or
IFU alongside the UKCA mark.
Another key player in this environment
will be the UK Approved Body. To
date, conformity assessments have been
carried out by EU Notified Bodies, but
they will not be able to provide UKCA
marks. UK organizations that were previously
acting as Notified Bodies are
now automatically UK Approved
Bodies, but unfortunately their numbers
are limited and stand at three. It is
evident that there is a very real risk of
these few UK Approved Bodies rapidly
becoming overburdened with high
demand for their services, so manufacturers
would do well to engage with one
early to ensure they are not held up by a
bottleneck.
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Medical Design Briefs - September 2021

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