A new white paper report commissioned by Abbott seeks to provide a constructive contribution to ongoing policy and legislative developments for medical devices and diagnostics. Its release comes as the new UK Government looks to refocus healthcare more towards prevention and closer to home through the use of the latest innovative technologies, and with a focus on regulatory innovation.
Medical devices and diagnostics play a critical role in preventing and treating some of today’s most prevalent health challenges, such as cardiovascular disease and obesity. This sector is also a dynamic and vital part of the UK economy, generating substantial turnover, supporting export activity, and providing employment for a diverse workforce. An effective regulatory framework is essential to ensure the continued growth and positive societal impact of this industry.
The new report, titled 'Navigating the Future: Medical Devices and Diagnostics Regulation in the UK', draws on insights from a range of experts across the industry, government, regulatory bodies, and clinical community. It seeks to inform the UK’s future regulatory framework post-Brexit, and makes a series of recommendations for the government and others to consider. These include:
- Communicating clarity, predictability, and certainty to the sector through a new Regulatory Roadmap with updated milestones and timings.
- Learning lessons from international contexts, including the implementation of medical devices and diagnostics regulations in the European Union.
- Enabling innovation by offering earlier scientific advice to manufacturers and driving efficiencies throughout the conformity assessment process.
In the report’s Foreword, Yuan Fang, Divisional Vice President for Global Strategic Regulatory at Abbott, comments: "As a global company, we recognise the potential for a new domestic framework to boost the attractiveness of the UK to global regulators and companies. The UK should aim to strike a balance between international harmonisation in many areas – to streamline decisions and reduce administrative costs and burden – whilst also establishing a national route to market that is globally competitive and incentivises companies to choose the UK first over other larger markets. The MHRA can be an effective sovereign regulator that is smartly positioned across a global regulatory landscape.”