European Union

MedTech Current regulatory intelligence and device recall publications for European Union.

Regulatory Intelligence14 October 2026

Norway consults on notified body costs, timelines and renewals

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.

Regulatory Intelligence10 September 2026

EU MDCG Clarifies IVDR Classification for Rule 7 Control Materials

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.