Regulatory Approval

Regulation is one mechanism that helps to balance the benefits the new technology brings with any risks.

New digital health technologies offer both challenges and opportunities. The global pandemic in 2020 accelerated the growth of this market whilst at the same time considering the regulations of such devices which are varied in their design, diagnostic and outcomes. Regulation is one mechanism that helps to balance the benefits the new technology brings with any risks. It supports innovations to challenge infrastructure and technical requirements in order to ensure their device/software is safe for patients to use and to gain the trust of the clinical teams using such technology as part of their clinical decision-making.

Regulatory approval supports innovations to challenge infrastructure and technical requirements in order to ensure their device/software is safe for patients to use and to gain the trust of the clinical teams using such technology as part of their clinical decision-making. The Digital Technology Assessment Criteria is becoming the recommended tool that brings together legislation and good practice to support businesses to assess their regulation and standards. It incorporates a checklist with references to other standards that need to be compliant i.e. DCB 0126 and cyber essentials. It outlines what is the minimum standard for entry to the NHS and social care.

The extensive market further complicates ‘what is good’ and ‘what is safe’ for those commissioners procuring such devices to achieve better outcomes and more efficient ways of working.

Medical Devices Regulation in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. In the current guidance, a “medical device” includes in vitro diagnostic medical devices and active implantable medical devices.

Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland).

These are:

• A new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market
• All medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market
• If you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration.
• CE marking will continue to be recognised in Great Britain until 30 June 2023
• Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
• The EU no longer recognises UK Notified Bodies
• UK Notified Bodies are not able to issue CE certificates – and have become UK Approved Bodies.

The MHRA has published its intention to set out UK legislation that will extend the standstill period during which CE marking is accepted in the UK for another year to July 2024. According to the MHRA, the planned transitions will then start from when the new regulations come into force, alongside new post-market surveillance requirements.

It must be stressed that this is not in legislation yet and we encourage you to check the MHRA web site for further updates and information.

Digital Technology Assessment Criteria (DTAC) is developed by NHSX is a new advisory assessment criteria for the commissioning of digital health technologies. The standard gives staff, patients and citizens confidence that the digital health technologies that they use meet the NHS minimum baseline standards.The DTAC will ensure products meet NHS standards in: clinical safety, data protection, technical security, interoperability, and usability and accessibility. Whilst it is not currently mandatory, the DTAC brings together legislation and recognised good practice into one place, helping the system to assess products quickly and consistently. Digital health suppliers should consider the legislative requirements in any build. For digital health suppliers, the DTAC sets out what is expected for entry into the NHS and social care. It is also used by healthcare organisations to assess suppliers at the point of procurement, or as part of a due diligence process.