The EU is now well on its way to completing the roll out of its new regulatory system for medical devices. The Medical Devices Regulation is now in force, and the In Vitro Diagnostics Regulation will follow next May.
Meanwhile, the UK is taking the opportunity offered by Brexit to steer a different course. A recently launched MHRA consultation proposes a national system that aligns closely with best practice developed by the International Medical Device Regulators Forum, while adopting measures to ensure patient safety and promote innovation.
The consultation addresses the overall objectives that must be considered when updating regulations under the Medicines and Medical Devices Act 2021, namely -
- likelihood of the UK being seen as a favourable place in which to carry out research, conduct clinical trials, develop new products, and manufacture and supply products.
It covers the following areas.
- Scope, expanding to include non-medical products like coloured contact lenses, for example.
- Classification, aligning with international rules, and improving clarity.
- Economic operators, clearer allocation of responsibilities and addressing insurance requirements.
- Registration and UDI, using a central data system to improve safety.
- Approved Bodies
- Conformity Assessment
- Clinical Investigation / Performance Studies
- Post-market Surveillance
- IVDs, increasing the level of scrutiny these attract.
- Software/AI as a MD, defining software as “a set of instructions that processes input data and creates output data”, tracking IMDRF classification rules and tightening requirements on cyber security and distance sales.
- Implantable Devices
- Product specific changes
- Environment/public health
- Routes to market
- Transitional arrangements
We noticed a few eye-catching proposals:
- An ‘airlock classification rule’ which would defer final classification of software products while their risk profile is better understood.
- Recognition of certifications from other parts of the world, with some additional review, plus participation in the international Medical Device Single Audit Programme.
- A light touch pathway for innovative products, especially those developed by SMEs or targeting rare conditions or small patient groups.
The review is extensive and wide-ranging, and is worth engaging with at this stage in order to shape next steps. The consultation closes on 25 November. A new framework would follow, to coincide with the end of the recognition period for CE marking in June 2023. Several possible transitional arrangements are set out to support businesses in achieving compliance.
This development sits alongside plans in the Health and Care Bill to expand the collection and management of information about medicines. This, together with existing powers to collect information about devices in the Medicines and Medical Devices Act 2021, will see a more coherent and coordinated body of data available to the MHRA in carrying out its monitoring and supervisory functions. The regulator will be able to combine routinely collected data with bespoke data extracted from other systems and obtain better visibility of the safety and benefit profile of products.