MHRA Policy Paper on Medical Technology strategy: a future MedTech landscape for the UK medical sector

Medical technology, also calledMedTech“, is a vital part of the healthcare system. It includes a wide variety of goods, from plasters and bandages to complex devices, such as in-vitro diagnostic medical devices, or even software that uses cutting-edge technologies. Regardless of their function or complexity, MedTech devices are all designed to improve people’s health. With this objective in mind, the United Kingdom is developing a solid MedTech strategy. 

Need for a more robust future MedTech strategy in a complex healthcare system 

The Covid-19 pandemic brought the importance of MedTech to light; such experiences should be used for a more robust future MedTech strategy. Considering that MedTech is a vital industry for the UK economy, laying out a structured groundwork can also have financial benefits, spur innovation, and lead to a robust international market presence. Moreover, due to the increasing pressure on the UK health and care system, driven by demographic, financial, and Covid-19 factors, the UK government must take aligned and coordinated action towards MedTech. Considering these factors, the UK Government issued a policy paper earlier in February 2023 on the matter. 

The rising healthcare needs of the UK: a catalyst in developing a solid governmental approach to MedTech 

The policy paper presents a review of the existing UK MedTech sector and identify priorities, considering the challenges and the potentially lengthy timeline of such an undertaking.  

The objectives of developing a sound MedTech strategy rest on three pillars: 

  • Right product, a product that is safe for all, is effective and innovative. 
  • Right price (value for money). 
  • Right place, i.e., availability, resilience, and ease of access. 

Achieving a balance between these three objectives can produce an optimal result. To ensure these goals are attained, many changes in the regulatory framework must follow, supporting innovation, guaranteeing sustainability, and ease of access to a demographically varied country such as the UK. 

Call for future action 

Based on the abovementioned priorities, UK authorities hope to shift focus accordingly concerning MedTech strategy over a timeline of 5 to 10 years. Of course, this procedure must consider many factors and challenges, meaning that a realistic approach to timelines is essential. To do so, the Medtech Directorate will be setting up the framework for achieving the aims of the strategy, and the Director of Medtech will be overseeing the activities in the sector. Finally, the authorities will seek stakeholder engagement to better develop the implementation plan.  

The role of your UK Responsible Person 

Obelis UK Ltd., as part of the services it provides for clients in the UK market, engages daily with compliance of MedTech devices, ensures they are compliant with all the relevant UK regulations and that all necessary activities are undertaken for the Registration of Medical Devices on the MHRA portal. A better-set strategy on behalf of the UK authorities regarding medtech will also increase commercial opportunities for innovative MedTech products to be placed in the UK market, a role which Obelis UK Ltd. can help its clients achieve. 

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Nikolaos Chatzistavrou 
UK Regulatory Affairs 
05/04/2023 
 

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