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New framework for international medical device recognition is hugely promising move Header Template

New framework for international medical device recognition is ‘hugely promising move’

4 minutes
Posted: 27-May-2024

A new statement of policy intent from the Medicines and Healthcare products Regulatory Agency (MHRA) has been hailed by an expert as a “great step forward” for British medical device manufacturers

Last week, the MHRA announced it was formally exploring a proposed framework for international recognition of medical devices through alternative routes to market which it believes “signals an important step” towards simplifying regulatory approvals.

The statement outlines the UK Government’s intended new approach to reducing duplication of assessments by recognising approvals from relevant national bodies residing in member states of the European Union and European Economic Area, the United States’ Food and Drug Administration (FDA), Health Canada, and Australia’s Therapeutic Goods Administration (TGA).

The MHRA says its announcement continues to provide “a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need, and ensures the UK remains an attractive market for medical technology innovators”.

Formal NHS Scotland partner InnoScot Health considers the proposed framework to be a key route to realising the aim of international recognition.

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell said: “On paper, it’s undoubtedly a hugely promising move.

“The MHRA’s ultimate aim of reducing duplication of assessments by comparable regulators and enabling greater focus on innovation is a laudable one when it comes to accelerating access to safe, quality-assured medical devices for improved patient outcomes.

“Announcing the statement of policy intent now allows manufacturers to start the process of considering whether their devices will be eligible for the proposed alternative routes to market.

“At the same time, the MHRA is also keen to stress that manufacturers will still have the option of using UK Conformity Assessed (UKCA) marking to access the British market so it is aiming to open new doors but not shut any.”

Elaine continued: “While still a draft framework at this point, if seen through fully – and the MHRA seems confident of achieving that given the full detail of its announcement – then it will encourage SME’s to prioritise innovation, access larger markets and represents more efficient use of resource.”

Dr Laura Squire, Chief Quality and Access Officer of the MHRA said: “We will continue to work on how our intended policy on international recognition of medical devices will operate in practice.

“By sharing the draft policy now, we aim to give greater clarity about the MHRA’s future direction of making regulatory approvals simpler, where it is safe to do so. At the same time, we remain fully committed to the UKCA marking for medical devices.

“We continue to expand capacity in UK Approved Bodies and to work to ensure UKCA marking supports safe and earlier access to the most innovative and transformative medical products.”

The MHRA continues to review comparable regulator countries and is currently in discussions to explore the recognition of medical device approvals from Japan through the Pharmaceuticals and Medical Devices Agency (PMDA).

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Complying with medical device regulation

InnoScot Health offers a skilled team of regulatory experts. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive.

Consultancy, training and advice is available to all NHS health boards, plus companies or universities working in partnership with NHS Scotland to develop medical devices. We ensure awareness and compliance with legal responsibilities and support the design and development of products under an accredited regulatory framework.


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