Following Britain’s exit from the European Union, the regulatory landscape governing companies in the life sciences sector is under regular review.
The current framework for medical devices in the UK is set out in the Medical Devices Regulation 2002, which implemented the EU Medical Devices Directives. However, the EU regime has been significantly updated by the Medical Devices Regulations 2017/745 (which aim to improve the safety of medical devices), and whilst these regulations have been applicable in the EU since 26 May 2021, they do not apply in Great Britain and have not been implemented into UK law.
The Medicines and Healthcare products Regulatory Agency (MHRA) was heavily involved in the development of the 2021 EU legislation and strongly supported the need to update the current Medical Device Directives and the UK Regulations. As such, in September 2021 the MHRA published its 15 chapter consultation on the regulatory framework that will govern medical devices in the UK. This consultation predominantly focused on patient safety, transparency and innovation whilst recognising that gaining and maintaining competitiveness in a global market is best supported by alignment with internationally recognised standards, and with the EU Regulations.
On 26 June 2022, the MHRA published the UK Government’s response to that consultation, and its intentions for the future of the UK regulatory regime for medical devices to ‘support safe innovation and ongoing access to products’ and make the UK a favourable place to research, develop, manufacture and supply medical devices.
The response states that the medical device regulatory framework will be built on five key pillars:
1. strengthening MHRA power to act to keep patients safe;
2. making the UK a focus of innovation;
3. addressing health inequalities and mitigating biases throughout medical device product lifecycles;
4. proportionate regulation which supports businesses through access routes that build on synergies with EU and global standards; and
5. setting world leading standards through the new UKCA mark.
With the five pillars in mind, the MHRA intends to alter the UK Regulations as set out below:
Scope of the Regulations
It has plans to amend the definitions of medical devices in line with international guidance, and extend the scope of the UK Regulations to include some non-medical products with a similar risk profile to medical devices, such as dermal fillers, tattoo and hair removal lasers, and coloured contact lenses. Registration of such products with the MHRA will therefore be required.
Classification
Following broad sector and other technological advances, the MHRA expects to progress the classification changes highlighted in the consultation in recognition that existing medical device classification rules in the UK no longer align with best international practice. With that in mind, there will be a reclassification of certain products as has taken place in the EU.
Economic Operators
The MHRA intends to strengthen the accountability of manufacturers, importers and distributors engaged in the supply of medical devices, with a view to enhancing safety standards. Some key changes include:
- Various obligations relating to the UK Responsible Persons (UKRP) will be set out in the UK Regulations, including legal liability for defective medical devices on the same basis as the manufacturer;
- In a similar vein to the role of the Person Responsible for Regulatory Compliance in the MDR and IVDR, the manufacturer and UKRP should have access to a qualified person to support regulatory compliance.
- Greater obligations will be placed on importers and distributors to help improve traceability.
- Where there are any issues that will interrupt supply or cause a shortage of medical devices on the UK market, economic operators will be required to inform the MHRA.
Registration and UDI
There is strong support to make improvements in the area of device registration, including proposals for the introduction of a globally harmonised device identification and coding system, which allows unambiguous identification of a specific device on the UK market. Before being placed on the UK market, medical devices will require assignment of a Unique Device Identifier (UDI) and a registration database for medical devices will be established.
Conformity Assessment
The intention is to bring in ‘essential requirements’ for medical devices in line with the EU MDR and EU IVDR. Where a manufacturer is seeking to obtain ‘conformity assessment’ by demonstrating equivalence with a device that is already on the market, the MHRA intends to introduce requirements that the device a manufacturer is claiming equivalence to should be ‘entirely equivalent’ to the manufacturer’s device, on a biological, physical, and clinical basis. The response states it is hoped this approach will help mitigate the risks of ‘product creep’, where new devices become very different from their ‘equivalent’ devices.
Alternative Routes to Market
There was strong support to introduce routes to market that avoid duplication and minimise burden on industry, promoting international collaboration with like-minded regulators while maintaining regulatory oversight.
Post-market surveillance
The UK Regulations will be amended to clarify and strengthen the requirement for manufacturers to implement a post-market surveillance system in respect of all medical devices they have placed on the UK market. Definitions of ‘serious incident’, ‘serious deterioration’ and ‘serious public health threat’ will be included in the UK Regulations.
Liability of Compensation
Manufacturers will be required to have measures in place (such as sufficient financial coverage) to provide recompense to those affected by adverse incidents related to medical devices, with such requirements being proportionate to the type of device, risk class and size of company.
Software as a medical device (SaMD)
A new definition of ‘software’ will be included in the UK Regulations, currently proposed as follows: ‘A set of instructions that processes input data and creates output data’.
The classification rules in the UK Regulations will be amended to include the International Medical Device Regulators Forum (IMDRF) SaMD classification rules for general medical devices, to allow for international alignment. This is likely to lead to up-classification of software, which was one of the areas that industry hoped the MHRA may offer more discretion compared to the EU MDR. Further essential requirements will be introduced to assure the safety and performance of SaMD specifically, including cybersecurity and data protection issues, similar to those in the MDR.
With regard to AI as a medical device (AIaMD), the MHRA does not propose to define AIaMD or set out specific legal requirements beyond those being considered for SaMD.
Other changes
- For the moment, the MHRA does not plan to introduce any changes to the scope of medical devices regulated as implantable medical devices. Additional rules around post-market requirements will be introduced, such as the supply of information about devices to patients and the use of implant cards.
- Additional requirements will be placed on UK Approved Bodies who will be required to hold appropriate UKAS accreditation. Further, the MHRA intends to allow Approved Bodies to conduct fully remote or hybrid audits of their clients in specific circumstances.
- The UK Regulations will be amended to be more internationally aligned and will introduce additional requirements for assemblers of systems, kits and procedural packs.
- Components that make a significant change to the safety and performance of a medical device will be regulated as medical devices in their own right.
- More detailed requirements relating to technical documentation and some stringent requirements for the post-market surveillance for custom-made devices will come into effect.
- The MHRA also noted there is significant support for introducing requirements for claims made about medical devices to ensure that these accurately reflect the safety, performance and intended purpose of the medical device.
- The intention is to drive better environmental outcomes that compliment or enhance patient safety.
Summary
The above listed proposals bring the UK regime in line with the requirements set out in the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), and refer to international definitions and guidance from the IMDR.
The MHRA has stated its aim is to create and have in force a new regulatory regime by 1 July 2023 that will apply in Great Britain (England, Wales and Scotland) to coincide with the requirement that all medical devices must be UKCA marked to be placed on the market in Great Britain.
Whilst the Government response clarifies and sets out in more detail the approach the MHRA intends to take in amending the UK Regulations, no draft statutory text has yet been published. Additional detail will also be left to guidance that will accompany the UK Regulations, so the key message here is to watch this space.
Finally, following a recent announcement that the MHRA has been accepted as a full member of three international work-sharing partnerships, the UK is set to play a much greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide.
To discuss how the new Medical Devices regulatory regime may affect your business, please contact Katie Carter or Danny Lee.