EU MDR / IVDR

Downloadable EU MDR GSPR checklist template for Annex I evidence mapping, applicability, standards, gap analysis, ownership, and remediation tracking.

Learn the 10 most common EUDAMED registration mistakes before the May 28, 2026 mandate, including data, UDI, actor, certificate, and workflow errors, plus fixes.

Regulatory guide for home-use and self-test IVDs, covering FDA OTC and CLIA pathways, EU IVDR self-testing, human factors, labeling, specimen errors, and PMS.

Protocol-level guide to IVD analytical validation, covering LoD, LoQ, precision, interference, cross-reactivity, stability, CLSI methods, and FDA/IVDR evidence.

Assess medical devices with nanomaterials, including EU MDR Rule 19, FDA guidance, ISO 10993-22, exposure frameworks, nanotoxicology, sterilization, labeling, and regulatory strategy.

Regulatory strategy for NGS IVD devices, covering FDA pathways, EU IVDR classification, companion diagnostics, bioinformatics validation, and postmarket controls.

Use this EU MDR PMCF plan template to define objectives, methods, endpoints, timelines, reports, PMS integration, and MDCG 2020-7 traceability.

Regulatory strategy for pre-filled syringes and auto-injectors, covering FDA OCP/RFD, ISO 11608, human factors, EU MDR Article 117, QMSR, stability, and lifecycle changes.

Regulatory strategy guide for surgical robots, covering FDA pathways, EU MDR expectations, autonomy levels, software controls, human factors, and clinical evidence.

Practical guide to RUO, IUO, and IVD labeling boundaries, covering intended use, FDA guidance, diagnostic-use triggers, marketing risk, and classification decisions.

Guide to the 2026 EU MDR Well-Established Technology delegated acts, expanded device lists, clinical investigation exemptions, conformity assessment changes, and manufacturer steps.

Guide to medical device benefit-risk analysis, covering ISO 14971 residual risk, EU MDR AFAP expectations, FDA benefit-risk factors for PMA, De Novo, and 510(k), examples, and documentation.

Demonstrate clinical equivalence under EU MDR Article 61 and Annex XIV, including MDCG 2020-5 criteria, data access, gap analysis, and CE marking examples.

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.