Medical devices – regulatory reforms in the EU and the UK

Ongoing reform across the medical devices regimes in both the EU and the UK aim to ensure patient safety while providing a practical and proportionate system for manufacturers and innovators. So far, experience with the revised EU system has been difficult and a review process is under way. As the reform of the UK regime is rolled out, we’re expecting to see a greater degree of flexibility and proportionality that may help to avoid some of the difficulties being faced in Europe.

EU – review of the MDR and IVDR

In the EU, the updated legislation for medical devices (the Medical Devices Regulation 2017/745) and IVDs (the in vitro Diagnostic Medical Devices Regulation 2017/746) have been in place for some time now. However, it’s been difficult for the industry to achieve full compliance, as is shown by repeated extensions to the transition periods. Following the Draghi report on EU competitiveness, the European Parliament called for urgent revisions to this legislation, highlighting significant challenges faced by industry and proposing solutions to ensure the availability and safety of medical devices across the EU.

MedTech Europe has stressed the need to take immediate action, emphasising that “urgent measures are needed now to address devices availability, the delays in certification, regulatory bottlenecks, and disproportionate burdens on small and medium-sized enterprises (SMEs), which threaten innovation and access to medical technologies in Europe.”

The EU has initiated a review and consultation, to identify what improvements might be made. This is open for input until 21 March.

It's too early to say what changes will result, but this is an opportunity to input with a view to making the system more user-friendly and practical.

UK – ongoing reform process

Meanwhile, the UK is moving forward with its own modernisation programme following an extensive review and consultation process. This aim is to introduce a modern system, offering improved safety and transparency, a strong environment for innovation and alignment with international best practice. An updated schedule for these changes can be accessed here.

Already in place is the post-marketing surveillance (PMS) update. This addresses what was seen as the most pressing aspect of the overall package following the Independent Medicines and Medical Devices Safety (IMMDS) review. The revised legislation will come into force 16 June 2025 and covers the following areas:

The key changes include:

• Detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.
• Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.
• Clearer obligations on manufacturers to consider conducting a Field Safety Corrective Action (FSCA) to prevent or reduce the risk of a further serious incident, and detailed requirements relating to Field Safety Notices (FSN)
• Requirements for manufacturers to conduct periodic reviews of PMS data, including for implantable devices, in order to enable earlier detection of trends/signals that may have an impact on safety.

The MHRA has published detailed guidance to support manufacturers ahead of the implementation date. This includes a suite of device-specific vigilance guidance, including on software as a medical device.

Other aspects of the device reform package are undergoing final revisions before draft legislation is put before Parliament. A recent consultation focused on the following areas:

• International reliance – The intention is to supplement UKCA marking with an extensive international reliance scheme to facilitate quicker market access. The list of comparable regulator countries will initially include Australia, Canada, the EU and the USA, with ongoing discussions aimed at adding Japan.
• UKCA marking – MDs must currently carry a UKCA marking to be placed on the GB market if they have undergone the UK conformity assessment process, where practical and appropriate. These marking requirements may be removed for MDs which undergo the UKCA process, if this can be effectively replaced through new UDI requirements.
• IVDs – IVDs will be classified in four risk classes in line with their level of risk, with each class having different requirements for the IVD to gain market access. The system differs somewhat from the EU system, with a view to controls being more risk proportionate.

The MHRA has indicated that it is aware of the need for regulation to be proportionate, so that patients can access the care that they need. On software, for example, where innovation is especially rapid, the intention is to take a “regulation light and guidance heavy” approach. Given the experience to date of the EU system, proportionality and responsiveness remain a priority for the medical device sector.

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