European Union

How medical device manufacturers structure customer transition plans when software reaches end of support, mapping required evidence, IMDRF milestones, and surviving duties.

How FDA guidance and the EU MDR decide which device models one test report covers, and which records justify an untested size or configuration.

When a laboratory may adopt an IVD manufacturer's reference interval, when CLIA requires verification or establishment, and what ISO 15189 adds only for accredited laboratories.

A practical decision guide to UDI placement across medical device packaging levels under FDA, EU MDR, and TGA rules, covering carriers, unique identifiers, and shipper exemptions.

A manufacturer guide to EU MDR Article 1(8) and 1(9): classify integral ancillary devices, medicinal products, and administration devices with the four-scenario identity worksheet.

A medical device RA/QA guide to records custody when changing distributors: who keeps complaint and traceability files under US, EU, and Canadian post-market rules.

How medical device RA/QA teams reconcile units, ISO symbols, and released versions across translation cycles before artwork issuance under FDA QMSR 820.45 and EU MDR GSPR 23.

When a supplier change notice omits affected lots, dates, or technical details, device QA must hold unverified product, issue an evidence request, and halt close-out until facts are verified.

Evaluate whether a configurable EDC study build can reconstruct device models, firmware versions, deficiencies, and endpoint records for FDA and EU MDR trials.

MDCG 2026-4 EUDAMED SSCP and SSP upload guide: NB interim duties, manufacturer handover in October 2026, Article 32 vs 29(4), and the 27 February 2027 clock.

Operational guide to ISO 20417:2026: FDA Rec# 5-149 complete recognition, the July 1 2029 DoC transition window, ISO 15223-1, 21 CFR 801, and EU MDR GSPR 23.

FDA DHT clinical investigation guide: investigational device vs remote measurement tool under 21 CFR 812, fit-for-purpose V&V, and August 2026 DDM status.

IEC 62353 in-service electrical safety testing: manufacturer IFU duties, IEC 60601-1 type test differences, CMS S&C 14-07 major repair rules, and NFPA 99.

Manufacturer ISO 80369 conversion guide: route-specific particular parts, FDA recognition transition windows through Dec 17, 2028, and 510(k) change forks.

MHRA and NHS England 2026 guidance on ambient voice technology (AVT): 9-example medical device qualification tree, Class I vs IIa, DCB0129, and UKCA strategy.

MDCG 2026-5 UDI assignment guide: 3-path decision tree for private-label distributor brands, MDR Article 16, Basic UDI-DI rules, and EUDAMED registration.

Operational guide to US investigational device expanded access: emergency use, compassionate use IDE supplements, Treatment IDE (21 CFR 812.36), and IRB rules.

Playbook for NSAI NB 0050 clients on the 2026 divestment: confirmed facts, stay-vs-transfer tree, MDR Article 58, IVDR Article 53, MDSAP.

Complete guide to medical device TMF and ISF: ISO 14155:2026 Annex E essential documents, 21 CFR 812.140, EU MDR archiving, and device-unique artifacts.

Comprehensive guide to IVDR Chapter VI performance studies: Article 58 application triggers, Article 70 PMPF notifications, Article 66 timelines, leftover samples, and safety reporting.