Transition from CE to UKCA certification for medical devices - 12 May 2022
colleagues have contacted Council with concerns about provision of medical
equipment when the transition occurs from CE to UKCA (UK Conformity Assessed)
certification. As you are no doubt aware, following the UK leaving the EU, CE
approval is being replaced by a new certification – UKCA in Great Britain. As I
understand it, the CE will continue to be used in Northern Ireland unless a UK
Nominated Body is making the application for NI in which case a UKNI
certificate is needed (this may possibly change). For those of you wanting a
more in depth summary see here: Regulating medical devices in the UK.
The concerning issue for congenital services including cardiology, cardiac
surgery and ICU is withdrawal of equipment and devices essential for us to
provide safe services to our patients.
I have discussed these issues with leading catheter companies, distributors,
interventional colleagues, CRG and the MHRA to try to clarify the issues, the
results of which I summarise:
- Transition deadline. CE marking
will continue to be recognised in Great Britain until 30th June 2023.
- All medical devices with a valid
CE mark can continue to be placed on the market until this date.
- After that date a UKCA mark
will be required with submissions made by a Nominated Body.
- MHRA consultation process. Last
year the MHRA initiated a consultation process (of which BCCA was unaware)
that concluded Nov 2021. The consultation on the proposed changes can be
found here- Consultation on the future
regulation of medical devices in the United Kingdom - GOV.UK (www.gov.uk).
This included possible transition arrangements for devices that already
have a CE or UKCA mark, and alternative routes to market for medical
devices. The MHRA are currently analysing the responses received and a
formal response to the consultation will be published shortly, setting out
the transition to the new regulatory regime.
- Provision of medical equipment.
My conclusion from discussion with some of the catheter companies is that
there will likely be consolidation of their range of products, both in the
UK and the EU jurisdictions. This is due to the costs of the process in
the UK and EU which are recurring as well as the administrative burden.
- Septostomy catheters. There are
particular concerns about future availability of these catheters following
previous consolidation of products on the market. I have been informed
that there is a likelihood of one (and possibly two) new products becoming
available which should help safeguard future supply.
I can assure you that the BCCA will follow these issues closely and
particularly await the results of the consultation process which should provide
clarity about transitioning arrangements and how they affect our provision of
I have written to the MHRA and National Supply Disruption Response (NSDR)
to represent our views as well as informing NHS(E), NHS Scotland
and NHS Wales of our concerns.
Prof Piers Daubeney
12 May 2022
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