EU MDR / IVDR

Guide to electronic IFU rules for medical devices, covering EU Regulation 2025/1234, FDA 21 CFR Part 801, website access, QR codes, paper fallback, IVDR, SaMD, and validation.

Buyer-side breakdown of EU medical device registration costs in 2026, comparing EC REP hourly, registration-plus-annual, and flat-fee pricing with three-year scenarios.

Build an EU MDR literature search protocol for clinical evaluation, covering Article 61, Annex XIV, MEDDEV methodology, PICO, databases, appraisal, PRISMA, and Notified Body expectations.

Use PRO instruments in medical device trials with fit-for-purpose validation, endpoint planning, FDA CDRH expectations, EU MDR evidence, and submission strategy.

Build a defensible SOTA review for EU MDR clinical evaluation, with comparator selection, benchmark devices, outcome parameters, MDCG evidence hierarchy, and CER examples.

Compare Swiss CH-REP pricing models for 2026, including Pure Global flat fees, hourly billing, registration-plus-annual fees, and 3-year cash flow scenarios.

Practical GDPR guide for device and IVD manufacturers, covering health data, DPIAs, DPO duties, lawful bases, transfers, EU MDR, IVDR, and AI Act overlap.

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.