On December 31, 2020, the Brexit transition phase ended, along with the validity of EU regulations in the UK. Since leaving the EU, the United Kingdom (UK) has been struggling with corresponding hurdles. There is a shortage of workers in some sectors, sales to the EU have decreased, and there have been significant costs associated with the adjustment of administration and customs duties. The MedTech regulations in the UK also fall under these adjustments. At the time of its withdrawal from the EU, the UK was supposed to fall under the jurisdiction of the EU MDR. As this plan did not work out, the UK MDR was implemented instead.

The UK MDR includes the requirements of its EU MDR predecessors: Active Implantable Medical Devices Directive (AIMDD), In Vitro Diagnostic Medical Devices Directive (IVDD), and Medical Devices Directive (MDD). Therefore, in January 2024, the Medicines & Healthcare Products Regulatory Agency (MHRA) published a roadmap to improve patient safety. It pays particular attention to post-market surveillance, which is to be strengthened in the future. What exactly does the roadmap envisage? Which transitional regulations will continue to apply to medical devices? And what alternative is there for the EU CE marking?

CE marking in Great Britain: UKCA

Since the end of the transition period, a CE marking equivalent called UKCA (UK Conformity Assessed) has been available for the MedTech industry in the UK. Its issue is dependent on compliance with the UK MDR. However, the CE mark is still permitted, although with a deadline.

• Medical devices in compliance with the MDD and AIMDD can be sold until June 30, 2028, or until their declaration of conformity expires, whichever comes first.
• In-vitro-diagnostic devices in compliance with the IVDD may be sold until June 30, 2030, or until their declaration of conformity expires, whichever is earlier.
• Medical devices in compliance with the MDR, including custom-made devices and in vitro diagnostic devices in compliance with the IVDR may be sold until June 30, 2030, or until their declaration of conformity expires, whichever is earlier.

Also, the sale of MDR Class I devices with self-declared CE marking is regulated until after June 30, 2023. There are two exceptions to this. On the one hand, this applies to self-declared products with conformity according to the MDR. They also could be sold until June 30, 2030. On the other hand, self-declared products according to the MDD are included, for which the involvement of a notified body is not necessary. Additionaly, upgraded products and reusable surgical instruments can be sold until June 30, 2028. However, the sale of custom-made products with MDD and AIMDD approval is no longer possible.

The medtech industry’s wishes for post-market surveillance

In the wake of Brexit and the forthcoming changes to the MDR, the MHRA opened a feedback round on PMS. The participants summarized four wishes that should be taken into account in the future:

• Alignment with EU regulations to bring economic and operational benefits to manufacturers.
• The involvement of patients should be set out in a post-market surveillance plan.
• Future guidelines should provide more detailed information on the aspects to be considered.
• The level of detail required should be determined using a risk-based approach.

Overall, the medtech industry in the UK would like to see greater clarity for future PMS regulations. Furthermore, a plan to this effect has also already been published. So far, manufacturers are only required to maintain a PMS system. However, what such a system should achieve is only set out in recommendations and is not required by law.

Planned implementation of post-market surveillance requirements

A publication from the World Trade Organization dated July 26, 2023, addresses the planned changes to the PMS in the UK. The proposals:

• Detail what needs to be part of a PMS system, including methods for collecting PMS data, to support improved collection and harmonization across manufacturers.
• Improved reporting requirements for serious incidents by manufacturers, to support early detection of safety issues.
• Stricter requirements for manufacturers to conduct regular reviews of their PMS data, including for implantable medical devices. That intends to help manufacturers identify trends and signals that could affect the safety of a medical device at an earlier stage.

However, it is unclear to what extent the wishes of the medtech industry in the UK are being addressed, as too few details have been published to date. One exception is the inclusion of patients. This point is to be ensured by improving the obligation to report serious incidents. According to the document, June 2024 has been proposed as the date for entry into force. However, the MHRA’s more recent roadmap indicates the end of the year as the deadline.

The new UK Approved Bodies

With the withdrawal from the EU, Notified Bodies will no longer be accredited to carry out conformity assessment procedures for medical devices. The UK-Approved Bodies will therefore become their equivalent. However, as the UK MDR is based on the former European requirements. Its procedures correspond to the AIMDD, IVDD, and MDD. As a result, manufacturers of Class I devices do not need to undergo a conformity assessment procedure by a UK-approved body and therefore, do not have to adapt to significant changes.

Update [10.10.2024]

The UK government has outlined a comprehensive plan to streamline the approval process for medical devices by recognizing approvals from certain international regulators. Regulations included here are those of Australia, Canada, the European Union, and the United States. Additionally, there are restrictions for certain products with 510(k) clearing and for some product types (e.g. AI-based products). This initiative aims to ensure timely access to safe medical devices for patients in the UK. At the same time, it tries to support innovation and maintain the UK as an attractive market for medical technology.

Key Points:

• International Recognition: Streamlined approval process by recognizing international regulators.
• Transitional Arrangements: Extended acceptance of CE-marked devices to ease the transition.
• Future Regulatory Framework: Focus on patient safety, innovation, and market attractiveness.
• Ongoing Activities: Continuous stakeholder discussions will be held to refine the framework.

Timeline:

• 2024: Priority measures to enhance post-market surveillance.
• 1 July 2025: Core elements of the new regulatory framework in place.
• 30 June 2028: CE-marked general medical devices compliant with EU MDD or EU AIMDD can be placed on the GB market.
• 30 June 2030: CE-marked IVDs compliant with EU IVDD and general medical devices compliant with EU MDR can be placed on the GB market.

The UK’s intended approach is to ensure system readiness and minimize supply disruptions to pave the way for a safer and more innovative healthcare landscape.

[Disclaimer]

This information is only one possible interpretation of the regulations. Also, they are in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: May 2024)