A consultation has been
launched by the Medicines and Healthcare products Regulatory
Agency (MHRA) on proposed changes to the regulatory requirements
a medical device must meet before it is placed on the market in
Great Britain. The consultation will close on 5 January 2025.
The consultation will focus on four policy areas that have
evolved significantly since the MHRA's initial consultation to strengthen
medical devices legislation was launched in 2021. These four
areas, described below, are part of broader regulatory reforms
that respond to recommendations set out in the Independent
Medicines and Medical Devices Safety (IMMDS) review and that
support the development of a regulatory framework that enables
transformative technologies to reach patients as quickly and
safely as possible.
The findings from this latest consultation will inform new
legislation, the Pre-market Statutory Instrument, which we expect
to be laid in Parliament next year. This follows the laying of
The Medical Devices
(Post-market Surveillance Requirements) (Amendment) (Great
Britain) Regulations in Parliament on 21 October 2024.
Together, these reforms will boost UK patients' access to safe
and innovative medical products, and will help the government's
efforts to eradicate health inequalities, get the NHS back on its
feet and kickstart growth across the country.
The four policy areas that the MHRA is consulting on are:
1)UKCA marking
Medical devices, or their sterile pack, currently need to have a
UKCA (UK Conformity Assessed) marking to be placed on the Great
Britain (GB) market. The MHRA is introducing new requirements to
improve device traceability by assigning devices with a Unique
Device Identification (UDI), which reduce the need for a UKCA
marking. The MHRA is therefore seeking views on whether to remove
the requirement for physical UKCA marking.
2)International reliance
International Reliance is a mechanism whereby certain medical
devices could access the GB market more quickly if they have
already been approved by a comparable regulator. This was
originally proposed in the government response to the 2021
consultation but since then the policy approach has developed
substantially, and the MHRA now wants to seek views on a detailed
policy framework for International Reliance.
3)In vitro diagnostic (IVDs) devices
IVD devices will be classified in four risk classes based on the
patient and public health risk they pose. Each class has
different requirements for an IVD device to gain market access,
according to its risk level. The MHRA is seeking views on the
regulatory requirements for Class B IVD devices to gain market
access.
4)Assimilated EU law
The MHRA is seeking views on a proposal to remove the revocation
date of four pieces of assimilated law so that they remain part
of the statutory framework for medical devices in Great Britain
until the transition to an updated medical devices regime. The
four pieces of law are:
- Commission Decision 2002/364 on the common specifications for
in vitro diagnostic medical devices
- Commission Regulation (EU) No 207/2012 on electronic
instructions for use of medical devices
- Regulation (EU) No 722/2012 concerning particular
requirements for medical devices manufactured utilising tissues
of animal origin
- Regulation (EU) No 920/2013 on the designation and the
supervision of approved bodies.
This proposal – alongside more specific transitional provisions –
would ensure a smooth transition to a future regulatory
framework, which aims to protect patient safety, improve access
to innovative medical devices, and support innovation.
You can take part in the consultation here. The MHRA
welcomes views from all interested stakeholders.
