MHRA organised a very informative webinar on 5th of Mar 2024 to provide update on the upcoming changes in the UK Medical Devices Regulation (UK MDR).

They mentioned several reasons behind the update in MDR. It is updated to include medical devices which are out of the scope of the current regulation. It also aims to increase the alignment with international classification for medical devices (International Medical Device Regulators Forum – IMDRF). Another key change is to improve patients’ safety.

1. Post market surveillance – High risk devices will require additional safety monitoring; Proactive safety monitoring and reporting of major incidents to the MHRA. The additional safety monitoring will inevitable have impact on the overall cost for clinical research for the manufacturers, however this is an important part of patients’ safety oversight.

2. Increased alignment with international requirements (IMDRF) – The new regulation will change the definition for medical device to include the ‘intended purpose’ of the device. The manufacturer has to define the intended purpose and this should be consistent. This is implemented to reduce the risk of misuse. It will affect devices which are not classified as medical devices but have similar patient risk to medical devices – for example, dermal fillers, coloured contact lenses.

MHRA presented how the qualification for the medical devices will change in the UK.

3. In Vitro Diagnostics (IVD) definition will be modified to include software. It also clarified that IVD could be used to provide information on mental or physical impairment, or to predict treatment response. IVDs will be classified as class A (low risk), B, C and D. Class B, C and D will need conformity assessment by approved body. In class C will be included devices for screening, detecting and diagnostic of neurodegenerative and cardiovascular diseases; some companion diagnostics. In class D will be included medical devices for monitoring life-threatening infectious diseases.

MHRA showed during the webinar a visual guidance on how to determine the class of the IVD.

MHRA has provided excellent visual presentation to show what IVDs which were not currently covered by the MDR will be included in the new UK MDR.

4. The definition of Software as medical device will be changed to – A set of instructions that processes input data and creates output data. MHRA will also set pre-market requirements for testing. Software as medical devices will be separated into class I, IIa, IIb and III.

MHRA presented how the Software as medical device classification will change as shown below.

5. UK classification will be in line with EU MDR classification as much as possible.

6. Devices for IV fertilisation and assisted reproduction technologies will be class III. Active therapeutic devices with integrated or incorporated diagnostic functions will also be included in class III.

7. Devices that incorporate nanomaterials; devices composed of substances or combination of substances which will be introduced to the body will classify as class IIa-III. This will include some cosmetics products which currently are outside of the scope.

8. There will be additional information required for medical devices: specification and description of clinical benefit; increased traceability (specific requirements for UDI for class III; serial number on active implantable devices; serial and lot number on implantable devices); increased requirements for biosafety information.