Topic archive
MedTech Current publications and recall entries tagged EU MDR/IVDR.
The UK government intends to recognise EU MDR- and IVDR-compliant devices indefinitely in Great Britain, with separate arrangements for MDD legacy devices. Legislation remains subject to parliamentary approval; UKCA and domestic registration and surveillance obligations continue.
Norway proposes to incorporate EU rules on notified body quotations, assessment timelines and re-certification. Comments are due by 9 December 2026; Norwegian commencement remains to be determined, and EU transition rules depend on agreement and certificate expiry dates.
MDCG 2020-16 rev.5 clarifies the classification rationale and practical examples for Rule 7 control materials under IVDR, establishing key distinctions between unassigned Class B controls and assay-specific materials.
HSA’s supplementary change-notification guidance for EU MDR/IVDR transition changes is no longer current and is listed as archived. Registrants should now assess EU-driven labelling, IFU, and other changes under the current GN-21 R7 change-notification framework.