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Scotland is making positive regulatory steps all the time thanks to expert support Header Template

Scotland is making positive regulatory steps all the time thanks to expert support

4 minutes
Posted: 16-May-2024

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell, explores the trajectory of medical device innovation prior to MDMC Conference

Here in Scotland and across the UK, I believe that there are positive signs to indicate that we are increasingly getting the regulatory balance right for medical device innovators.

The path to getting products into patients’ hands remains tricky to navigate in many respects, particularly in terms of international harmonisation, but globe-straddling ambitions are being supported and barriers broken down.

Improvements are being realised all the time with the Medicines and Healthcare products Regulatory Agency (MHRA) making sustained efforts to help further innovation aspirations and provide a clear ‘roadmap’ for the development of new and robust regulations in the UK.

Right now, it is more important than ever that we forge ahead to allow innovative healthcare trailblazers to take advantage of an ever-broadening spectrum of technologies and breakthroughs.

Patients must also continue to get access to the devices they need as quickly as possible – but of course safety must always come first, the MHRA’s top priority.

Scotland undoubtedly offers a world-leading environment for MedTech innovators working within a regulatory framework which fully recognises their needs in tandem with patient-centred requirements – from opening up fresh horizons for accelerating preventative and proactive care, to honing transformative tech such as artificial intelligence (AI) and implantable devices.

The MHRA has a firm eye on keeping pace with AI, while its ‘roadmap’ has a key focus on patient inclusion which is very positive for ambitions to ensure success as the process moves forward.

I am also pleased to see MHRA’s commitment to strengthening the requirements for quality management systems (QMS) and technical documentation, as well as plans for better aligning essential requirements for medical devices in Great Britain with those of the EU.

Underpinning it all is the incredible power of collaboration across NHS, industry, and academia, whether pooling innovation-led know-how and resources, or overcoming challenges together and tapping into opportunities for making cutting-edge medical devices both viable and available for deployment.

Today’s exciting MedTech advances continue to evolve – and the regulatory framework is ready to continuously improve around them with expert guidance close to hand if sought through the right channels.

These key themes will be among those explored at the at the 3rd annual Medical Device Manufacturing Centre (MDMC) Conference, held at the Glasgow University Union on 23 May.

Elaine is chairing the morning session of the conference, which will bring together “expert speakers from industry, NHS and academia to drive life sciences and healthcare innovation”.

The MDMC is a consortium of institutions including Heriot-Watt University – where it is headquartered – the University of Edinburgh, the University of Glasgow, and Robert Gordon University.

InnoScot Health 'expertise' carousel image, featuring some of our members of staff and our hot pink brand colour.

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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InnoScot Health works in partnership with NHS Scotland to identify, protect, develop and commercialise new innovations from healthcare professionals. Registered Number: SC 236303. Registered address: 272 Bath Street, Glasgow, G2 4JR
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