ARTICLE SUMMARY:
The UK has extended regulatory transition timelines for devices and IVDs. Excerpted from Pathways’ Picks May 3: Reimbursement Picks, UK Extensions, LatAm Harmonization.
Following recent transition extensions enacted for the EU Medical Device Regulation, the UK government has followed suit for its own device/IVD regulations. Under legislation sent to the UK Parliament on April 28, devices and IVDs CE marked under the legacy EU directives and the new EU regulations (MDR/IVDR) will be able to stay on the Great Britain market longer before having to seek country-specific UKCA marks. (The EU MDR and IVDR will continue to apply in Northern Ireland.) Currently, the UK regulation established after it separated from the EU is slated to kick in on July 1, 2023, with the transition periods that give MDR-certified devices (and all EU-certified IVDs) an extra five years (and EU directive-certified devices three years) to get a UKCA mark. If Parliament approves the new measure, the start date will move to July 2025, pushing the transition deadlines to 2030 for MDR devices and IVDs and 2028 for directive devices. The UK Medicines and Healthcare products Regulatory Agency (MHRA) also said it is planning a further amendment to make it clear that device firms won’t be able to renew EU MDR/IVDR certificates as a means to remaining on Great Britain’s market after July 1, 2025.
