The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a consultation period calling on the public and private bodies for input as it looks to make changes across four key areas including UKCA marking, in vitro diagnostic devices and retaining European Union (EU) law.
The consultation period comes as the government body seeks advice from patients, medical device researchers, and medical staff, and the government looksto make reforms since its last consultation period in 2021. Top of the MHRA’s agenda is the new UK Conformity Assessed (UKCA).
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The MHRA is introducing new requirements to improve device traceability by assigning devices with a Unique Device Identification (UDI), which they say will reduce the need for a UKCA marking. As a result, the body is now seeking views onwhether to remove the requirement for physical UKCA marking.
Additionally, the body is looking to make changes to the system known as International Reliance. A mechanism whereby certain medical devices could access the UK market more easily if they have already been approved by a comparable regulator. Changes to this system were initially proposed as part of the 2021 consultation period but resulted in no meaningful legislative changes. Now, the MHRA wants to seek views on a detailed policy framework for International Reliance.
Third on the agenda, the MHRA is turning its attention to the regulation of In Vitro Diagnostic (IVD) devices, seeking views on the regulatory requirements for Class B IVD devices to gain market access. Typically, in the UK, IVD Devices are classified in one of four categories. Class B is the default class that takes in all IVD devices that are not covered specifically in other classification rules.
Lastly on the agenda, the body is seeking input on a proposal to remove the revocation date of four pieces of European Union (EU) law still remaining within the UK system in the years since Brexit.
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By GlobalDataThese include four laws pertaining to common specifications for in vitro diagnostic medical devices, electronic instructions for the use of medical devices, utilising tissues of animal origin, and the designation and supervision of approved bodies. The MRHA is hoping to keep these rules in place.
Speaking as a ministerial forward to the proposals, Parliamentary Under-Secretary of State for Patient Safety, Women’s Health and Mental Health, Gillian Merron, said: “This government was elected on a manifesto to fix the broken healthcare system, deliver economic growth and usher in a decade of national renewal. The UK has a world-class life sciences and MedTech ecosystem that – with the right regulation – can make an immeasurable difference to patients’ experience of the National Health Service and boost the nation’s economy.
“New technology can help to treat patients more effectively, diagnose illnesses sooner or prevent them altogether, improving outcomes for everybody. For example, at the end of May, there were over 1.6 million people waiting for key diagnostic tests. We must diagnose patients earlier and ensure that they have access to the medical devices they need.”
The consultation period follows shortly after the MHRA launched a new business plan to build on athree-year corporate plan, with the aim of garnering public trust. Notably missing from the consultation period is any mention of artificial intelligence (AI), something which the MHRA in the past has expressed interest in regulating.
