CE Marking

On May 7, 2026, the EU Council and Parliament reached a provisional deal to simplify AI Act rules. This guide breaks down what changed, what the product safety exemption means for medical devices, the new compliance timelines for AI-enabled SaMD and IVDs, and what manufacturers must do now.

A complete guide to Commission Implementing Regulation (EU) 2026/977, published May 4, 2026, which sets uniform quality management and procedural requirements for Notified Bodies conducting conformity assessments under the MDR and IVDR. Covers maximum timelines, clock-stop rules, quotation transparency, re-certification procedures, and what manufacturers need to know.

A practical survival guide for IVD manufacturers facing the May 26, 2026 IVDR Class C transition deadline. Covers who must apply to a Notified Body, the September 2026 agreement deadline, conditions for extended market access through 2028, common pitfalls, and a step-by-step action plan.

A practical guide to the April 2026 MDCG updates affecting every EU medical device and IVD manufacturer. Covers MDCG 2021-24 Rev.1 classification guidance changes, EMDN v3/2026 code updates (MDCG 2026-1, 2026-2, 2026-3, MDCG 2021-12 Rev.2), the Borderline and Classification Manual Version 5, and what manufacturers must do to stay compliant.

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.

Downloadable GSPR checklist template for EU MDR Annex I compliance — covering all 23 requirements across three chapters, with columns for applicability assessment, evidence files, harmonised standards mapping, gap analysis, owner assignment, and remediation tracking. Practical alternative to gated competitor templates.

Complete guide to demonstrating clinical equivalence under EU MDR Article 61 and Annex XIV — technical, biological, and clinical characteristics per MDCG 2020-5, differences from MEDDEV 2.7/1 Rev. 4, data access requirements, gap analysis, and practical examples for CE marking.

Step-by-step guide to creating a compliant literature search protocol for medical device clinical evaluation under EU MDR Article 61 and Annex XIV — MEDDEV 2.7/1 Rev. 4 methodology, PICO framework, database selection, inclusion/exclusion criteria, critical appraisal, PRISMA documentation, and Notified Body expectations.

Complete guide to conducting a state of the art (SOTA) review for medical device clinical evaluation under EU MDR — regulatory definitions, SOTA methodology, comparator and benchmark device selection, clinical outcome parameters, MDCG 2020-6 evidence hierarchy, and practical examples for building a defensible CER.

Deep walkthrough of all 22 EU MDR classification rules in Annex VIII — non-invasive, invasive, active, and special rules — with MDD-to-MDR changes, software and nanomaterial up-classification, MDCG 2021-24 guidance, and practical strategies for correct device classification.

Everything manufacturers need to know about EU MDR Common Specifications — Article 9 legal basis, Annex XVI products without medical purpose, Implementing Regulation (EU) 2022/2346, reclassification under (EU) 2022/2347, Class D IVD common specifications, presumption of conformity, and transitional timelines through 2028.

How to draft a fully compliant EU Declaration of Conformity under MDR Article 19 and Annex IV — content requirements, language obligations per Member State, legacy device considerations, digital DoC proposals for 2026, and a complete annotated template covering Class I through III devices.

How to demonstrate compliance with all 23 General Safety and Performance Requirements (GSPR) under EU MDR Annex I — chapter-by-chapter walkthrough, GSPR checklist template, harmonised standards mapping, cybersecurity and AI updates for 2026, and practical strategies for Notified Body submissions.

How harmonised standards work under EU MDR Article 8 — the complete 2026 list including Implementing Decision (EU) 2026/193, presumption of conformity mechanics, GSPR mapping methodology, the 17% harmonisation gap (48 of 277 standards), MDCG 2021-5 guidance, and practical compliance strategies for manufacturers facing the 79% regulatory grey zone.

Comprehensive guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16 — including EUDAMED registration, labeling requirements, QMS obligations, verification checklists, and the MDCG 2021-27 Q&A guidance for economic operators.

How to prepare, validate, and publish the Summary of Safety and Clinical Performance (SSCP) under EU MDR Article 32 — MDCG 2019-9 Rev.1 template walkthrough, HCP and layperson sections, readability testing, Notified Body validation process, translation requirements, EUDAMED upload timelines, and common NB findings in 2026.

How much does medical device registration cost in 30+ countries? Side-by-side comparison of government fees, total project costs, and timelines across the US, EU, Brazil, Japan, South Korea, India, China, Saudi Arabia, UK, Australia, Canada, Singapore, and more.

A complete guide to the European Commission's December 2025 proposal to simplify MDR and IVDR. Covers the new Rule 11 for software, indefinite certificate validity, regulatory sandboxes, breakthrough and orphan device pathways, fixed conformity timelines, SME fee reductions, and the expected legislative timeline through 2027.

The definitive 2026 cost reference for ANVISA medical device registration — exact government fees by class in BRL and USD, BGMP audit costs and schedules, MDSAP carve-outs, ANATEL wireless fees, INMETRO electrical safety certification, and Brazilian Registration Holder retainer ranges.

Strategic analysis of dual CE Mark + FDA 510(k)/PMA approval showing the multiplier effect across 25+ markets, country grouping matrix, and concrete cost/timeline comparisons for manufacturers pursuing both pathways.