In early March, the MHRA presented a webinar to discuss the upcoming changes to the Medical Device regulations for the UK. From the webinar, it is quite clear that the MHRA is doing their best to align the new regulations with the MDR and IVDR.
Various topics were discussed in this webinar and will be clarified below.
General Themes
- There will be three Statutory Instruments, Post-Market Surveillance, Future Core Regulation and Future Enhancement Regulation.
- The MHRA will prioritise environmentally sustainable options when it comes to IFU’s, allowing for manufacturers to provide e-IFU’s wherever possible.
- Software as a medical device (SaMD) has been defined as “a set of instructions that processes input data and created output data.” This newly introduced definition of SaMD is intentionally broad to allow flexibility of qualification on future technologies. It will also include Artificial Intelligence as a Subset.
- The essential requirements of the new legislation will be closely aligned to the General Safety and Performance Requirements of the MDR and IVDR, however as expected they will reference UK law as opposed to EU Law.
Classification
- The classification of Medical Devices will align closely to the MDR. That being said, there will be an addition of a rule for devices that are directly related to the process of In-Vitro Fertilisation (IVF) or assisted reproduction technologies (ART), more specifically, where these substance-based devices come into contact with human embryos prior to implantation. Such device will be classified as high-risk Class III devices.
- For Software as a Medical Devices, that are not considered IVD’s, the MHRA will adopt the classification framework highlighted in the IMDRF document: “Software as a Medical Device”: Possible Framework for Risk Categorization and Corresponding Considerations.” This document describes four distinct risk categories, ranging from Category I to Category IV. It is worth noting that this classification framework aligns closely with Rule 11 of the MDR.
- For In-Vitro Diagnostic Medical Devices, the MHRA will adopt the classification criteria based on the IMDRF Guidance Document: “Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.” Similar to the IVDR, there are 4 distinct risk categories ranging from low-risk Class A to high-risk Class D. There will be some additions for devices which monitor infectious loads of life-threatening infectious diseases, such as the Ebola virus which will be classified as Class D, and devices that are intended to be used for screening, detecting or diagnosing neurodegenerative diseases or cardiovascular diseases, will be classified as Class C.
Timelines
There were no specific dates that were discussed in the webinar, that being said, reference was made to the roadmap that was published earlier this year. they also stated that there was no intention of delaying the implementation of these regulations.
Useful Links
The roadmap highlighting the timescales for the Implementation of the Future Regulations can be accessed using the following link
To view the IMDRF document “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.” Kindly click the following link
To view the IMDRF document “Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.” Kindly click the following link
