EU MDR / IVDR

Medical device glossary with 100+ FDA, EU MDR, quality system, clinical evidence, standards, cybersecurity, and regulatory acronyms explained for professionals.

Guide to FDA and EU MDR regulation of cloud-based medical devices and SaaS health platforms, covering SaMD, SiMD, IEC 62304, cybersecurity, CSA, CRA, and validation.

Classify mobile medical apps under FDA and EU MDR rules, including device software functions, wellness exclusions, CDS updates, Rule 11, cybersecurity, privacy, app stores, and 2026 strategy.

How to register medical devices in Switzerland under Swissmedic: CH-REP duties, MedDO/IvDO rules, swissdamed deadlines, CE reliance, fees, and PMS obligations.

Guide to wearable medical device regulation in the US and EU, including FDA wellness policy, 510(k), De Novo, EU MDR classification and manufacturer compliance strategy.

Explains how the EU CRA and NIS2 affect medical device companies, including MDR/IVDR exemptions, indirect CRA exposure, supply chain duties, and deadlines.

Walk through all 22 EU MDR Annex VIII classification rules, including invasive, active, software, nanomaterial, and special rules with 2026 guidance.

Guide to EU MDR Common Specifications under Article 9, including Annex XVI products, IVD common specifications, conformity effects, and timelines through 2028.

How to draft an EU MDR Declaration of Conformity under Article 19 and Annex IV, including required content, language rules, legacy devices, and templates.

Guide to demonstrating compliance with EU MDR Annex I GSPR, including all 23 requirements, evidence mapping, standards, cybersecurity, AI, and NB review tips.

Guide to EU MDR harmonised standards under Article 8, including the 2026 list, presumption of conformity, GSPR mapping, MDCG guidance, and compliance gaps.

Guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16, including registration, labeling, QMS duties, checks, and MDCG guidance.

Guide to the EU MDR Person Responsible for Regulatory Compliance, covering Article 15 qualifications, duties, outsourcing, MDCG guidance, liability, and 2026 changes.

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.