European Union

In-depth analysis of Bayer's acquisition of Perfuse Therapeutics for up to $2.45 billion, marking its return to M&A after a 5-year drought. Covers the PER-001 intravitreal implant for glaucoma and diabetic retinopathy, deal structure, endothelin receptor antagonism mechanism, the growing drug-device combination product market, and what it means for ophthalmic medtech manufacturers and investors.

GE HealthCare announced a sweeping restructuring of its business segments and executive leadership team alongside Q1 2026 earnings that missed expectations. Facing $250M in inflationary cost increases driven by memory chips, oil, and freight, the company is raising prices and cutting its profit outlook. Covers the new Advanced Imaging Solutions segment, leadership changes, the inflation impact on medtech supply chains, and what device manufacturers should expect.

Sun Pharmaceutical Industries agreed to acquire Organon & Co. for $11.75 billion in the largest pharmaceutical deal of 2026 and India's largest overseas pharma acquisition. Covers deal structure, Organon's portfolio of women's health products (Nexplanon, NuvaRing) and biosimilars (Hadlima, Renflexis), the drug-device combination products involved, regulatory considerations for combination products, and what the deal means for the women's health and biosimilar device landscape.

In-depth analysis of Danaher's $9.9 billion acquisition of Masimo, the largest medtech deal of 2026. Covers deal structure, strategic rationale, regulatory and antitrust considerations, competitive landscape impact on patient monitoring, and what it means for device manufacturers, hospitals, and investors.

Comprehensive guide to the EU's new Breakthrough Device (BtX) framework under MDCG 2025-9 and the EMA pilot program launching Q2 2026. Covers eligibility criteria, application process, benefits for manufacturers, comparison with the FDA Breakthrough Device Program, and what this means for IVD companies.

Detailed analysis of MedTech Europe's May 2026 position paper on the proposed MDR/IVDR revision. Covers breakthrough/orphan pathways, cybersecurity, AI integration, IVDR-specific concerns, and what manufacturers need to know about the coming legislative process.

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.

Operational guide to the invalid-result workflow for home-use and self-test IVDs — covering invalid rate targets, lay-user error coding, repeat-test instructions, IFU comprehension, customer support scripts, specimen collection errors, adverse event handling, and postmarket trending.

Practical guide to change control for NGS bioinformatics pipelines in IVD devices — covering variant caller updates, reference database changes, threshold modifications, wet-lab/software interface validation, IEC 62304 documentation, revalidation triggers, and postmarket records.

Operational guide to converting an RUO-labeled assay or reagent into a cleared or approved IVD — covering marketing claims cleanup, distributor scripts, customer notices, historical data triage, validation bridge strategy, complaint transition, sales training, and evidence firewall construction.

Complete guide to the GLP-1 drug-delivery device landscape in 2026 — auto-injector pens, oral delivery devices, combination product regulatory pathways, FDA and EU MDR requirements, and market outlook.

An analysis of the EU MDR and IVDR Notified Body capacity crisis using 2026 survey data — 33,175 MDR applications vs 17,549 certificates issued, 13–18 month review times, IVDR Class C deadline, and a practical action plan for manufacturers facing certification gaps.

A comprehensive guide to regulatory sandboxes for medical devices — MHRA AI Airlock (£3.6M expansion), FDA TEMPO pilot for digital health, EU sandbox proposals, and how manufacturers can participate in these programs to accelerate market access.

How the EU Corporate Sustainability Reporting Directive affects medical device manufacturers — scope, ESRS standards, double materiality, timelines, Omnibus simplification, and practical compliance steps for MedTech.

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.

How Good Clinical Practice applies to medical device clinical trials — navigating ISO 14155:2026 and ICH E6(R3), sponsor and investigator responsibilities, informed consent, safety reporting, and audit readiness.

Protocol-level guide to cleaning validation for reusable surgical instruments — covering artificial soil selection, protein/hemoglobin/TOC endpoints, worst-case device families, manual vs automated cleaning, ANSI/AAMI ST98 acceptance criteria, sample size justification, and report structure.