This webpage was updated with the following information.
Post-market Surveillance (PMS)
The Post-market Surveillance timeframe was updated.
The previous text stated that the PMS legislation would be laid down winter of 2023 and was expected to apply from mid-2024. It now states that the PMS legislation is expected to apply towards the end of 2024.
Future Regulations
A new section was added, to provide details on the proposed new medical device regulation.
Currently, the UK legislation is based on the old EU Directives (MDD/AIMDD/IVDD). The MHRA intends to lay down new legislation, which will align more closely with the EU MDR/IVDR.
The current timing for the new legislation is:
First half of 2024 – stakeholder discussions
End of 2024 – draft legal text for public consultation (published by the World Trade Organization)
“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.”
The MHRA has granted a transition period, allowing CE Marked devices through 2028-2030 (depending on type of device). Implementation of the new UK medical device regulation (“UKCA Marking”) is currently not expected to change this.
Roadmap on the Future Regulatory Framework
The MHRA published a planned 2024-2025 roadmap.
It outlines the various stakeholder discussions expected to take place this year, and the overall timeframe to implement the new core UK medical device regulation.
To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
Functional
Always active
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
Preferences
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
Marketing
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.