CE Marking
26 articles
EUDAMED Day Zero: The Role-Specific Action Playbook for Manufacturers, Authorized Representatives, Importers, and Distributors (Final 50 Days Before May 28, 2026)
Role-by-role action playbook for the May 28, 2026 EUDAMED mandatory deadline — covering actor registration, UDI/device registration, certificate uploads, and market surveillance obligations with a countdown checklist and member-state penalty matrix.
Where Does Your CE Mark Actually Get You? The Global Reliance Map for Medical Device Manufacturers
A strategic map of 25+ countries where CE marking provides regulatory leverage — organized by mechanism: full reliance, abridged review, evidence-only acceptance, and reference-only. Know which markets your CE Mark unlocks and what extra steps remain.
Missed the May 26, 2024 MDR Notified Body Deadline? Your Emergency Exit Options for Legacy MDD Devices
Operational playbook for manufacturers that missed the May 26, 2024 Notified Body written agreement deadline under Regulation (EU) 2023/607 — covering legal status of non-qualifying devices, market withdrawal timelines, fresh MDR application routes, sell-off rules, and specific examples by device class.
How Much Does CE Marking Cost for Medical Devices? Complete 2026 Budget Breakdown
A data-driven breakdown of every cost component for CE marking under EU MDR — notified body fees, clinical evaluation, technical documentation, authorized representative, ISO 13485, and ongoing compliance costs with 2026-specific figures.
EU Authorized Representative (EC REP): Complete Guide for Medical Device and IVD Manufacturers
A comprehensive guide to EU Authorized Representative (EC REP) requirements under EU MDR and IVDR. Covers Article 11 obligations, mandate requirements, costs, PRRC obligations, EUDAMED registration, and how to select the right EU AR for your medical device or IVD company.
EU MDR and IVDR Transition Timeline: Legacy Device Deadlines (2026-2029)
A complete guide to EU MDR and IVDR transition deadlines for legacy devices. Covers Article 120 MDR and Article 110 IVDR transitional provisions, class-specific deadlines, conditions for eligibility, EUDAMED requirements, and practical steps to maintain EU market access.