Following Brexit, many changes have been introduced to how medical and in vitro diagnostic devices are placed on the market in Great Britain. At present, the changes involve secondary legislation. The manufacturers can choose to comply with the MD 93/42/EEC, EU MDR 2017/745, or UK MDR 2002 to place devices on the UK market until July 1, 2023.
To improve how medical and in vitro diagnostic devices are regulated in the UK, the Medical Devices Regulations 2002 will soon be amended. For this reason, between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the future medical device regulatory framework, which aims towards:
- improved patient and public safety, greater transparency of regulatory decision-making, and medical device information
- close alignment with international best practices, and
- more flexible, responsive, and proportionate regulation of medical devices.
The consultation involved responses from 413 individuals and 451 organisations. Considering the respondersā answers, the government responded to all the proposals, summarised in the report from June 26, 2022.
Scope of the Regulations and classification of devices
The government intends to expand the scope of the UK medical devices regulations to include specific products within the definition of a āmedical deviceā.
To improve patient safety, the MHRA will also proceed with preparing regulations reclassifying products. It will apply to certain implantable devices and non-medical products that may cause similar risks to medical devices.
The scope of the UK medical devices regulations will include the amended definition of an āin vitro diagnostic medical deviceā (IVD).
Quality Management Systems
The future medical device regulatory framework will require from all manufacturers an appropriate Quality Management System (QMS) addressing all applicable obligations. The requirements will be proportionate to the risk class of the medical device, including manufacturers of Class I, custom-made and general in vitro diagnostic medical devices (IVDs).
Further guidance by the MHRA on QMS requirements is expected.
Additional requirements for UK Responsible Person and manufacturers
The new regulations will bring significant changes for the UK Responsible Person (UKRP). Firstly, to ensure that UKRPs are based in the UK, uploading a āforwarding addressā to the registration system will no longer be possible. The new requirements will explicitly state that the UKRP must have an address in the UK at which they are physically located.
Secondly, after strong support from the responders, the government agreed to proceed with a proposal to clarify that the UKRP is legally liable for defective medical devices on the same basis as the manufacturer.
From the day new regulations come into force, the manufacturers will be obliged to have in place sufficient financial coverage for adverse incidents event. The liability insurance will have to be proportionate to the type of device, risk class and size of the company.
Transitional Arrangements
The government agreed to introduce provisions giving time to manufacturers to comply fully with the new regulations. The products already marked, either UKCA or CE, would be enabled to remain on the market for a period of 3 to 5 years after the new regulations come into force or until the certificate expires, whichever comes first. The transition dates will differ depending on the device and the rules under which the existing conformity mark was given.
The above deadlines will apply even if the certification/declaration of conformity is dated after the new regulations take effect.
What can we expect from the future regulations on medical devices?
The MHRA has received strong support to strengthen its power to act. It will be possible thanks to appropriate regulatory oversight.
Furthermore, the amended UK regulations will seek alignment with international and EU requirements and best practices. However, the UK’s new regulations will introduce stricter rules to ensure patient and public safety where necessary.
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Kamila Swiatek
18/08/2022
R&D Department
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References:
MHRA. (26/06/2022). Government response to consultation on the future regulation of medical devices in the United Kingdom. Gov.uk. Retrieved on 17/08/2022 from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085333/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf