On 5 March 2024, the UK MHRA (Medicines and Healthcare Products Regulatory Agency) held the MedTech Regulatory Reform Webinar. This online webinar provided insight into the UK government’s intentions for the future law on medical devices and IVDs. Specifically, the MHRA addressed the regulations’ scope, classification, and essential requirements.
In January 2024, the UK published the updated roadmap towards the future regulatory framework for medical devices. However, the general elections of next year might impact the current roadmap.
Takeaways of the MHRA MedTech webinar
The UK MHRA gave an overview of the future regulatory framework of medical devices and IVDs, which will be composed of 3 statutory instruments:
- Post Market Surveillance
- Future Core Regulation
- Future Enhancement Regulation
The overall objectives are patient safety, better alignment with international best practices, and promoting the UK as a favourable market for medtech companies.
Further points from the webinar:
- Broad definition of software as a medical device
- Inclusion of products without an intended medical purpose (such as dermal fillers) to the Future Enhancement Regulation
- In regards to classification, the future UK regulations will align with the EU MDR to a great extent. Software medical devices will follow the IMDRF risk categorization, while IVDs will be aligned with the IMDRF principles of IVD risk classification with some UK-specific cases (Class A to D as in the EU IVDR).
- Alignment of the essential requirements with EU MDR and IVDR General Product Safety Requirements, adapting it to the UK context. For example, referring to UK law instead of EU law.
- Inclusion on the labels of the following elements
- information about the (clinical) performance of the device, storage, shelf-life, biosafety information
- introduction of UDI with specific requirements for Class III, implantable devices
- instructions to report serious incidents
- envisage electronic IFU for some devices (e.g., for professional use)
The regulatory framework of medical devices is subject to many updates and changes. Check our news section dedicated to the compliance of medical devices in the European Union, the United Kingdom, and Switzerland.
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