But let’s see where it comes from.
The government has updated its guidance on the future of medical device regulation in Britain, stating that it aims for the future medical device regime to apply from 1.St June 2025.
Current regulations see acceptance of CE-marked medical devices on the UK market ending on 30 June 2023. The government intends to introduce legislation in spring 2023 to extend the acceptance of CE-marked medical devices in the UK market, which aims to support the safe supply of medical devices in the UK and ease the transition to the future regulatory framework.
The proposed legislation provides that CE-marked medical devices can be placed on the UK market within the following timeframes:
- General medical devices that comply with the EU Medical Devices Directive (EU MDD) or the EU Active Implantable Medical Devices Directive (EU AIMDD) with a valid declaration and CE marking can be placed on the market in Brittany until the date of expiry of the certificate or 30. June 2028
- In Vitro Diagnostic Medical Devices (IVDs) that comply with the EU In Vitro Diagnostic Medical Devices Directive (EU IVDD) can be placed on the UK market until the expiry date of the certificate or 30 before June 2030, i
- General medical devices, including custom-made devices, that comply with the EU Medical Devices Regulation (EU MDR) and IVDs that comply with the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) are may place on the UK market until the first day of expiry of the certificate or 30 June 2030.
This will allow certain CE-marked medical devices to continue to be placed on the UK market for longer.
Class I medical devices and general IVDs according to the directives, for which conformity assessment according to the EU MDD or the EU IVDD did not require a notified body, can only be placed on the UK market if the participation of a notified body is required under the EU MDR or IVDR (ie if it is an improved device or a reusable surgical device of class I). Custom-made devices that comply with the EU MDD or EU AIMDD can no longer be placed on the UK market.
If placing medical devices on the UK market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless those certificates have been deemed valid by the EU).
The government also intends to introduce legislation later in 2023 to bring strengthened post-market surveillance requirements into force ahead of the future wider regulatory regime. These post-marketing surveillance requirements are expected to apply from mid-2024.
The government also intends to make another amendment in the future. This provides that, once the future medical device regime is established, EU MDR or EU IVDR CE certificates that are renewed after the future regime is fully implemented (from 1 July of 2025) for the placement of medical devices. in the UK market.
You can read the full government update, here.
Ikaroa is dedicated to providing the latest technology news and developments, so it’s no surprise we are keeping a close eye on the most recent updates to the regulations of medical devices in the UK. The Department of Health and Social Care and Medicines and Healthcare products Regulatory Agency have released their vision for the future of medical device regulation in the UK, which will come into effect from 2021.
The main focus of the new regulations is to ensure the safety and conformity of medical devices for all users, with the aim of making it a simpler and more efficient process for users. This, in turn, should increase the use of innovative medical technology, which is exciting news for healthcare, medical device companies and technology providers such as Ikaroa who strive to push the boundaries of medical technology.
The updated regulations look to ensure that medical devices are easy to use, and thoroughly tested to ensure their safety. They will also be more tightly regulated, with better traceability and transparency of devices. These ideas are welcomed by the public and regulatory bodies alike, as the higher standards of testing and traceability should help to reduce medical errors.
The new regulations also provide more flexibility to users and professionals, allowing for a combination of pre-existing, internationally agreed standards and a level of discretion for individual situations.
Finally, the improved guidance for medical device companies should help foster better relations and transparency between regulators, product manufacturers and end-users. This should help to ensure that medical device companies, clinical researchers, healthcare professionals and patients can collaborate in a more effective way.
Overall, the updated guidance for the future of UK medical device regulation is welcomed by Ikaroa and all of our peers in the area of medical technology. We are excited to see how these changes will improve the quality of care that can be provided to patients, and to keep up to date with the industry. We look forward to continuing to provide innovative, cutting-edge technology solutions to support healthcare in the UK and beyond.