Services within controlled scope
Select the assessment route that matches your product, quality system and lifecycle stage. Final applicability is confirmed during application review.
Conformity assessment under Regulation (EU) 2017/745 for medical devices within NOTICE’s designated scope.
Quality-management-system certification for medical-device organizations within NOTICE’s accredited scope.
Surveillance, recertification, planned-change, scope-extension and other post-certification activities are managed as controlled projects.
Practical guidance
The applicant provides organization and device information in the secure portal. NOTICE confirms designation scope, classification, applicable codes and the proposed route during controlled application review.
No. MDD material is retained only for historical or transitional reference and is clearly separated from current MDR information.
