The UK Medical Device Regulation (MDR) 2002 is undergoing a number of incremental changes (rather than publishing a full new regulation) to update how medical devices and in vitro diagnostic medical devices (IVDs) are regulated. These amendments are designed to ensure the continued availability and safety of medical devices in Great Britain while fostering innovation and market stability.
The latest SI relates to the continued use of existing elements of the regulation, which were due to stop being used this month (the revocation date).
These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) by removing the 25th and 26th May 2025 revocation dates of the following pieces of assimilated EU law:
- Commission Decision 2002/364 (on common technical specifications for in vitro medical devices),
- Commission Regulation (EU) No 207/2012 (on electronic instructions for use of medical devices),
- Regulation (EU) No 722/2012 (concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin) and
- Regulation (EU) No 920/2013 (on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices).
The SI came into force on 24th May 2025 and apply to England, Wales, and Scotland.
Common Technical Specifications
The EU Common Technical Specifications (TS) for In Vitro Diagnostic Medical Devices (IVDs) provide detailed rules for certain high-risk IVDs, including those detecting or quantifying infectious agents like HIV, hepatitis, and SARS-CoV-2, as well as blood grouping tests. The specifications outline performance, safety, and quality requirements that these devices must meet to ensure they are safe and effective for use.
While the is additional burden required for Class D devices, the provision of common specifications allow manufacturers to greater understand the strategy for demonstrating safety and performance requirements, which can become challenging for lower risk class C devices.
eIFUs
Commission Regulation (EU) No 207/2012 focuses on the provision of electronic instructions for use of medical devices. It applies to manufacturers of IVDs and medical devices who opt to provide instructions for use in electronic form instead of paper if applicable. The manufacturers must meet specific conditions, including ensuring the electronic instructions are accessible and reliable, and have a clear indication that instructions are provided electronically must be included with the device. The electronic instructions must be easily accessible to users, including healthcare professionals and patients.
By removing these revocation dates, the amendments aim to allow the continuation of use of these regulations for the UK market access. This approach marks a common-sense approach in the short term, the alternative would have been to have UK specific requirements on the above, with possible divergence from the EU. The outcome of the continued use supports the aim to safeguard public health and ensure that the benefits of these regulations continue to outweigh any potential risks.
For further information on the transitional process for UK MDR, Common Technical Specifications, or the use of electronic IFUs, please contact [email protected]