On January 9th the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a significant update on the UK’s implementation of future regulations.
Currently the UK utilises legislation which was actively in use upon their departure from the European Union i.e. the Medical Device Directive and IVD Directives. The new legislation has gone through consultation processes and discussions, however the final text is yet to be seen.
In their publication, the MHRA sheds light upon their activities in 2023 and upcoming planned activities in 2024 related to the future regulations. Here is a description of their current timeline.
The MHRA is in the process of finalising legislation for 2024 to introduce post-market surveillance (PMS) requirements ahead of the future regulations. The publication states that these PMS requirements will be based on the draft PMS Requirements Statutory Instrument published by the World Trade Organisation (WTO) in July 2023, which includes:
- 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.
- More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.
During the first half of 2024, the MHRA is looking to holding furthers discussions on the future core regulations. The January publication includes the following elements as part of these regulations:
- Introduce several improvements for implantable medical devices; up-classifying them which will result in more stringent pre and post market requirements and requiring manufacturers to provide implant cards to enable patients to know which device they have had implanted.
- Ensure devices have a unique device identifier (UDI).
- Change the classification of several types of devices, specifically increasing the class of certain software as a medical device and aligning IVD classifications with those of the International Medical Device Regulators Forum.
- Strengthen the requirements for quality management systems and technical documentation.
- Introduce a framework for international recognition, enabling swifter access for devices already approved by comparable regulators as well as for those who have Medical Device Single Audit Program (MDSAP) certificates.
- Include new requirements for exempt in-house manufactured devices and custom-made devices.
- Include new requirements for the claims manufacturers can make about their medical devices requiring them to align with their statement of intended purpose.
- Include new requirements for clinical investigations.
- Bring the essential requirements for medical devices being placed on the market in GB into greater alignment with those of the EU. This will include cybersecurity requirements for software as a medical device including for artificial intelligence.
- Clarify the requirements for conformity assessments and approved bodies.
- Clarify the requirements for economic operators; manufacturers, importers and distributors, and introduce a requirement to have a Person Qualified in Regulatory Compliance.
From what we could see, efforts are being made to harmonise with EU and international regulators. There will definitely MHRA’s own flair on things, however, this shouldn’t be all too different from what we see in the EU Regulations.