The future of medical device regulations in the United Kingdom
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for medical device regulations in the UK.
Medical devices cover everything from artificial hips to wound dressings, incubators to infusion pumps and MRI scanners to scalpels. Medical devices under these regulations fall in to two categories:
- In vitro diagnostic medical devices (IVDs) use for testing samples such as blood and saliva, taken from the human body e.g., COVID-19 test kits and pregnancy tests.
- General medical devices that are usually used in or on the human body e.g., plasters, spectacles, and pacemakers.
Medical Device Legislation
Currently, medical devices are regulated under;
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
These directives are given effect in UK law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). These Regulations (in the form in which they existed on 1 January 2021) continue to have effect in Great Britain even after the Brexit transition period which ended on 31 December 2020.
This means that since 1 January 2021, the Great Britain route to market and UKCA marking requirements is still based on the requirements derived from current EU legislation.
Where are we now?
Since 1 January 2021, there have been updates to the UK Medical Devices Regulations 2002 – enabled through powers in the Medicines and Medical Devices Act 2021. The updates outline key requirements for placing medical devices on the market in Great Britain (England, Wales and Scotland).
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- For Great Britain, a UKCA marking will be required from 1 July 2023.
MHRA consultation on the future of medical device regulation in the United Kingdom
The MHRA is inviting members of the public to participate in a consultation to provide views on possible changes to the regulatory framework for medical devices in the UK.
The purpose of the consultation is to develop a future regime for medical devices which enables:
- Improved patient and public safety.
- Greater transparency of regulatory decision making and medical device information.
- Close alignment with international best practice.
- More flexible, responsive, and proportionate regulation of medical devices.
The MHRA welcome the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public to help shape future approach to regulating medical devices in the UK.
There are 17 chapters within the consultation, and you are encouraged to complete the chapters relevant to yourself.
The consultation is live and you can share your views by completing the online survey. This online survey closes on 25 November 2021 at 11:45pm.
The MHRA will then collate and analyse all responses and begin to identify emerging themes. Once analysed, a response to the consultation will be published. The MHRA will use the information gathered to inform the legislation. Regulations are to be in place by 1 July 2023.
Northern Ireland follows certain EU rules, with the Medical Devices Regulation (2017/745) (EU MDR) having taken effect from 26 May 2021. The EU in vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) will apply in Northern Ireland from 26 May 2022. A number of the proposals set out for consideration in this consultation could bring greater alignment with requirements in EU regulations and other international regimes – rather than bringing in higher regulatory burdens for the medical devices industry. This would ensure that consumers in Northern Ireland do not face barriers in accessing goods from Great Britain and enable goods made to UK legislation to circulate and be placed on the market in Northern Ireland.
If you have any questions, the specialist team at QA+ are happy to start the conversation.
Get in touch with us here.
- Medical device regulations – the future in the United Kingdom - October 15, 2021
- Protecting the UK medicines supply chain - October 4, 2021