Medical Device & IVD Blog

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

FDA permits substantial equivalence claims to devices no longer marketed in the U.S. Here is how to verify eligibility, satisfy 21 CFR 807.87(f), and build evidence without physical samples.

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.

How to classify Canadian medical device licence modifications into significant changes, statutory amendments, minor REP transactions, or annual renewals under SOR/98-282.

Compare AccessGUDID and FDA's establishment registration and device listing database to choose the correct public record for device identifiers, establishments, and listing status.

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.

Mark whether one 510(k) device change still owes a new filing, is covered by a cleared 515C PCCP, or is documented without a 510(k).

Mark whether one US reagent SKU is still an ASR under 21 CFR 864.4020 and 809.30, an RUO or IUO shipment, a general-purpose reagent, or a finished IVD with performance claims.

How to determine whether a US IVD clinical protocol qualifies for 21 CFR 812.2(c)(3) exemption, requires an abbreviated or full IDE, or falls under 21 CFR Part 312 IND rules.

A practical 21 CFR 4.4 worksheet for combination product facilities after QMSR: how to verify eligibility, separate-facility rules, and current ISO 13485 or drug CGMP streamlining clauses.

A practical 21 CFR Part 4 Subpart B worksheet mapping applicant identity, 4.102 baselines and add-ons, statutory reporting clocks, and electronic routing between FAERS, eMDR, and VAERS.

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.

A three-asset chain-of-custody crosswalk for medical device loaner exchanges: preserve serial traceability across removal, placement, and return without slot-level record overwrites.

A signed summary is not the deliverable. What protocols, complete reports, raw data, and archive terms medical device manufacturers must contract for premarket evidence and QMSR compliance.

A manufacturer intake worksheet for veterinary analyzer complaints: separate instrument observation, species and matrix, clinic QC evidence, and unsupported causality.

China NMPA GMP Announcement 107 operating guide: Order 53 manufacturing licenses vs 107 GMP, dual release, full-time key-person gates, and 1 November 2026.