EU MDR / IVDR

Explains the May 7, 2026 EU AI Act omnibus deal, product safety exemptions, revised timelines, and compliance actions for AI-enabled SaMD and IVDs.

Guide to Implementing Regulation (EU) 2026/977 for MDR and IVDR Notified Body assessments, including QMS rules, maximum timelines, clock stops, quotes, and recertification.

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.

Practical guide to April 2026 MDCG updates on MDR/IVDR classification, EMDN v3/2026 codes, the Borderline Manual, and manufacturer compliance actions.

Guide to building one evidence matrix for AI medical devices under EU MDR and the EU AI Act, mapping Annex II/III files, ISO 14971 risks, PMS/PMCF, cybersecurity, data governance, and QMS evidence.

Playbook for diagnosing EUDAMED bulk upload validation errors, including XSD failures, UDI mismatches, EMDN issues, certificate links, DTX codes, and pre-upload checks.

Structure PMSR and PSUR reports for devices sold in the EU and Great Britain, covering data periods, MHRA format, GB content, FSCA links, and retention.

Prepare an IVDR companion diagnostic consultation file for NB submission, covering EMA/NCA review, contents, performance evidence, drug label alignment, timing, and deficiency risks.

How to set MDR Article 88 trend reporting thresholds, choose denominators, test significance, escalate severity, link CAPA, and align PMSR/PSUR outputs.

Design EU MDR PMCF surveys that Notified Bodies accept, with sample frames, CER endpoint mapping, acceptance criteria, statistics, bias controls, and adverse event capture.

Playbook for responding to Notified Body SSCP deficiencies under EU MDR, covering response tables, clinical benefit wording, residual risk, readability, CER/IFU alignment, and EUDAMED readiness.

Track 2026 UDI compliance deadlines across the EU, Switzerland, Australia, China, Brazil, Singapore, and the US, with class rules and data requirements.

Guide to Switzerland swissdamed mandatory registration from July 1, 2026, covering UDI uploads, Product Module, CH REP duties, M2M, grace periods, and triggers.

Guide to the GLP-1 drug delivery device ecosystem, including auto-injector pens, oral delivery, combination product pathways, FDA, EU MDR, and market outlook.

Analysis of EU MDR and IVDR Notified Body capacity using 2026 survey data, review timelines, certification bottlenecks, IVDR Class C risk, and manufacturer actions.

Guide to CSRD sustainability reporting for medical device companies, covering scope, ESRS standards, double materiality, Omnibus simplification, timelines, and practical compliance steps.

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.

Apply Good Clinical Practice to medical device trials under ISO 14155:2026 and ICH E6(R3), with sponsor duties, consent, safety reporting, and audit readiness.

Use a section-by-section EU MDR CER template covering clinical evaluation plans, literature search, appraisal tables, equivalence, benefit-risk, PMCF links, and evidence traceability.

Practical guide to medical device CVD programs, including PSIRT setup, vulnerability intake, CVSS scoring, SBOM linkage, FDA Section 524B, EU expectations, and customer communication.