EU MDR / IVDR

Guide to ISO 15223-1 medical device symbols and labeling, covering the 2025 EU REP amendment, MDR/IVDR requirements, symbol validation, categories, and implementation.

Prepare an EU MDR Article 86 PSUR with class-based frequency, MDCG 2022-21 structure, EUDAMED submission, PMS data, and benefit-risk analysis.

Medical device SBOM guide covering FDA cyber device requirements, NTIA minimum elements, SPDX and CycloneDX formats, VEX integration, tooling, and postmarket management.

Learn how to prepare, validate, translate, and publish EU MDR SSCPs under Article 32, including MDCG 2019-9 Rev.1, lay summaries, NB review, and EUDAMED.

Guide to FDA and EU MDR rules for single-use device reprocessing, covering 510(k)/PMA needs, Article 17, Common Specifications, cost savings, and 2026 EU changes.

Guide to the European Commission MDR and IVDR simplification proposal, including software Rule 11, certificate validity, sandboxes, fees, timelines, and manufacturer impact.

Manage EU MDR Field Safety Corrective Actions, including FSCA triggers, 2/10/15-day reports, Field Safety Notices, EUDAMED, and FDA recall differences.

How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.

Guide to FDA and EU regulation of drug-device combination products, covering OCP jurisdiction, RFDs, 21 CFR Part 4, EU MDR Article 117, CGMPs, and post-market duties.

Role-by-role playbook for the May 28, 2026 EUDAMED deadline, covering actor registration, UDI/device data, certificates, surveillance duties, and final readiness steps.

See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.

What manufacturers should do after missing the 2024 MDR Notified Body deadlines, including legal status, withdrawal timing, fresh MDR applications, and sell-off rules.

Learn how the EU AI Act applies to AI-enabled medical devices, including high-risk classification, MDR/IVDR overlap, conformity assessment, and 2026 deadlines.

Register and commercialize medical devices in France with EU MDR, ANSM, EUDAMED, French labeling, LPPR reimbursement, CNEDiMTS, and CEPS requirements.

Market medical devices in Germany with EU MDR, BfArM, PEI, MPDG, EUDAMED, DMIDS, German labeling, clinical investigations, and DiGA strategy.

Guide to Italy medical device market access in 2026, including EU MDR, BD/RDM Repertorio registration, EUDAMED deadlines, Italian labeling, and HTA.

Register and market devices in the Netherlands under EU MDR, including IGJ oversight, CIBG Farmatec, NOTIS, Dutch labeling, EUDAMED, CCMO trials, notified bodies, and PMS.

Guide to marketing medical devices in Spain in 2026, covering EU MDR, AEMPS registration, Royal Decree 192/2023, EUDAMED deadlines, Spanish labeling, and regional notifications.

Plan a realistic 2026 CE marking budget under EU MDR, including notified body fees, clinical evaluation, technical documentation, ISO 13485, and ongoing compliance.

Guide to EU Authorized Representative requirements under MDR and IVDR, including Article 11 mandates, PRRC duties, EUDAMED registration, costs, and selection.