The European Union has recently amended the transitional timelines for EU Regulation 2017/745 – Medical Device Regulation (MDR) and Regulation 2017/746 – In-Vitro Diagnostics Regulation (IVDR). In parallel, the UK Medicines and Healthcare Products Regulatory Agency (UKMHRA) has been working to issue guidance on the implementation of Future Medical Device regulations in Great Britain.
In light of these developments, the UK government has updated its guidance on registering medical devices to be placed on the market. On April 27, 2023, an addition was made to the guidance on the registration of medical devices with an expired or expiring CE certificate that is valid under EU Medical Devices Regulations.
On April 28, 2023, the UK MHRA published a news update on medical devices – extended acceptance of CE-marked medical devices on the British market. This announcement is subject to Parliamentary approval and means that CE-marked medical devices will be accepted on the British market beyond the current deadline of 30 June 2023. The extension aims to provide businesses with more time to adjust to new regulatory requirements following the UK’s departure from the EU. During this extended period, businesses will be able to continue placing CE-marked medical devices on the market in Great Britain, provided that the devices meet certain conditions.
However, the UK government has also reminded businesses that they will need to take steps to comply with new UK regulatory requirements for medical devices as the UK MHRA will soon outline strengthened PMS requirements. This includes obtaining a UK Conformity Assessed (UKCA) marking and registering with the MHRA in order to continue placing devices on the market in Great Britain after the extended deadline. [Don’t take your ‘foot off the gas’. These transitional deadlines don’t mean relaxation on compliance. Rather, the manufacturers should take advantage of the extension and focus on ‘getting things sorted’ before the deadline proves to be fatal for the product.]
In addition to this, the UK Legislation website has published a draft Statutory Instrument related to The Medical Devices (Amendment) (Great Britain) Regulations 2023, which will update the UK MDR. Following the parliamentary process, these amendments will come into force on June 30, 2023.
As a Medical Device Manufacturer, you should focus on the following:
- Keep up-to-date with regulatory changes: With the recent updates to the transitional timelines and acceptance of CE-marked medical devices on the Great Britain market, it is important for manufacturers to stay informed about any regulatory changes that may affect their products. Manufacturers should regularly check the guidance on the UK government website and consult with regulatory experts to ensure they are aware of any updates and remain compliant.
- Review product portfolios and assess compliance: With the changes in the regulatory landscape, manufacturers should take this opportunity to review their product portfolios and assess compliance with the new requirements. This includes ensuring products meet the conditions for extended acceptance of CE-marked medical devices on the British market, obtaining UKCA marking, and registering with the MHRA. Manufacturers should also ensure they have a UK Responsible Person and take steps to comply with any other relevant regulations.
- Appoint a Representative: All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).Registration requirements differ for Northern Ireland. If the manufacturer is based outside of the UK, they must appoint a single UK Responsible Person to take responsibility for all of their medical devices. For UK companies looking to place their medical devices in the EU, appointing an EU Authorised Representative is Mandatory!
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