CE Marking
38 articles
Disposable Circumcision Device Supplier Qualification: CE, ISO 13485 & MOQ
A purchasing-control guide for qualifying disposable circumcision device suppliers: CE marking, ISO 13485 scope, size mix, MOQ landed cost, and sample acceptance.
EU MDR Article 22: Systems and Procedure Packs — Producer Obligations Guide
Complete guide to EU MDR Article 22 system and procedure pack producer obligations, the no-additional-CE-mark rule, Article 22(4) triggers, UDI, and the FDA convenience-kit comparison.
EU MDR Article 97 Derogations: Legacy Device Contingency Playbook
Comprehensive guide to EU MDR Article 97 derogations, including MDCG 2022-18, Addendum 1 restrictions, national competent authority processes, and contingency planning.
Moldova Medical Device Registry Teardown: AMDM Database Analysis
A data-driven teardown of Moldova's AMDM Register of Medical Devices: 20,339 records, country-of-origin share (China leads with 36.9%), and top authorized representatives.
Montenegro CINMED Medical Device Register Analysis: 15,179 Records
A data-driven teardown of Montenegro's CINMED Register of Medical Devices: 15,179 records, EU-aligned risk classes, IVD share, product categories, and local-holder concentration.
Serbia ALIMS Medical Device Register Analysis: 57,153 Records
A data-driven teardown of Serbia's ALIMS Register of Medical Devices: 57,153 records, EU-aligned risk classes, IVD share, country-of-origin, and authorized-representative concentration.
North Macedonia Medical Device Registry: MALMED Teardown & Analysis
A comprehensive analysis of North Macedonia's MALMED medical device register, detailing risk classifications, product categories, and local registrant landscapes.
EU-Switzerland MRA Update 2026: What It Means for Medical Device Market Access
How the EU-Switzerland MRA signed March 2, 2026 restores medical device mutual recognition, what changes for EU and Swiss manufacturers, swissdamed timelines, and the path to ratification.
Medical Device Accessory Classification: EU MDR and FDA Pathways
How accessories are classified separately from parent devices under EU MDR Article 2(2) and FDA 513(f)(6), with examples, MDCG 2021-24 Rev.1 updates, and FDA's 2025-2026 reclassification initiative.
Aesthetic Device Regulation: FDA 510(k) and EU MDR for Laser, RF, and Energy Devices
How energy-based aesthetic devices — laser, RF, HIFU, IPL, cryolipolysis, and EMS — are classified and cleared by FDA and EU MDR, including special controls, Annex XVI, and 2026 compliance updates.
EU AI Act High-Risk Classification Guidelines for Medical Device Manufacturers
EU Commission's May 2026 draft Article 6 high-risk AI classification guidelines: two-path system for medical devices, consultation deadline June 23, and compliance deadlines in 2027-2028.
EU MDR Article 59 National Derogation: CE Marking Exemptions
Practical guide to MDR Article 59 national derogations, including when non-CE-marked devices may be authorized, how reviews work, and manufacturer strategy.
EU AI Act Omnibus Amendment 2026: Medical Device Impact Guide
Explains the May 7, 2026 EU AI Act omnibus deal, product safety exemptions, revised timelines, and compliance actions for AI-enabled SaMD and IVDs.
EU Implementing Regulation 2026/977: Uniform Notified Body Requirements Under MDR and IVDR
Guide to Implementing Regulation (EU) 2026/977 for MDR and IVDR Notified Body assessments, including QMS rules, maximum timelines, clock stops, quotes, and recertification.
IVDR Class C Transition Deadline: What IVD Manufacturers Must Do Before May 26, 2026
Practical guide to the May 26, 2026 IVDR Class C deadline, covering Notified Body applications, the September 2026 agreement milestone, 2028 market access, and key pitfalls.
MDCG 2026 Updates: Classification, EMDN Codes, and Borderline Guidance
Practical guide to April 2026 MDCG updates on MDR/IVDR classification, EMDN v3/2026 codes, the Borderline Manual, and manufacturer compliance actions.
EU Notified Body Selection and Change for Medical Devices: 2026 MDR Guide
How to select, evaluate, and change Notified Bodies under EU MDR and IVDR — capacity constraints, selection criteria, transfer process, 2026 implementing regulation, and timeline planning.
EU MDR GSPR Checklist Template: Annex I Evidence Matrix for Technical Documentation
Downloadable EU MDR GSPR checklist template for Annex I evidence mapping, applicability, standards, gap analysis, ownership, and remediation tracking.
Clinical Equivalence Under EU MDR: Technical, Biological, and Clinical Criteria
Demonstrate clinical equivalence under EU MDR Article 61 and Annex XIV, including MDCG 2020-5 criteria, data access, gap analysis, and CE marking examples.
EU MDR Literature Search Protocol for Clinical Evaluation and CER Evidence
Build an EU MDR literature search protocol for clinical evaluation, covering Article 61, Annex XIV, MEDDEV methodology, PICO, databases, appraisal, PRISMA, and Notified Body expectations.