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News - UK Regulator Seeks Public Input on Long-Term Recognition of CE Marked Medical Devices

Image Credit: Gabrielle Henderson via Unsplash


February 2026 | Katie Ogden, Portfolio Manager – Pharma, SAE Media Group


The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on proposals that would shape how CE marked medical devices are recognized in Great Britain. The consultation focuses on the potential indefinite recognition of devices that meet European Union regulatory standards and is intended to gather views from stakeholders across the healthcare and medical technology sectors.

The consultation, which is open until 11:59 p.m. on April 10, 2026, invites feedback from individuals and organizations that may be affected by the proposals. This includes medical device manufacturers and distributors, trade associations, regulatory specialists, approved bodies, healthcare professionals such as clinicians, procurement professionals, devolved administrations, and patient representative groups.

According to the MHRA, the proposals are designed to provide regulatory clarity and continuity for medical devices placed on the Great Britain market. One proposal would extend the current transitional arrangements for devices that comply with the former Medical Device Directive. This extension would align Great Britain’s timelines with those set by the European Union for transitioning devices from the Medical Device Directive to the EU Medical Devices Regulation.

A second proposal would allow for ”he i’definite recognition of devices that comply with the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Devices Regulation. Under this approach, devices that meet these EU standards could continue to be placed on the Great Britain market without requiring additional conformity assessment under a separate domestic framework.

The MHRA is also seeking views on the introduction of an international reliance route for certain devices. This route would apply to products that are classified as higher risk in Great Britain than in the European Union. The agency is considering whether reliance on approvals from trusted international regulators could help streamline access to such devices while maintaining appropriate levels of safety and oversight.

The consultation applies specifically to medical devices in Great Britain. The MHRA noted that separate regulatory arrangements apply in Northern Ireland, where EU medical device regulations continue to be relevant under existing agreements. Guidance on the regulation of devices in Northern Ireland is available through the agency’s published resources.

The MHRA said it is seeking a broad range of perspectives to ensure that any future regulatory approach supports patient safety, access to medical technologies, and innovation, while also providing predictability for industry. Responses to the consultation will help inform the government’s next steps on the long-term framework for medical device regulation in Great Britain.
 

Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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