MedDeviceGuide — IVD & Medical Device Knowledge Base
IVD Reference Intervals: Established Values vs Local Verification
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.
Which Device Packaging Levels Need Their Own UDI Carrier?
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.
Canadian Medical Device Licence Changes: Which Filing Path Applies?
How to classify Canadian medical device licence modifications into significant changes, statutory amendments, minor REP transactions, or annual renewals under SOR/98-282.
AccessGUDID vs FDA Listing: Which Record Answers Your Question?
Compare AccessGUDID and FDA's establishment registration and device listing database to choose the correct public record for device identifiers, establishments, and listing status.
Is This Combination an MDR Device or a Medicinal Product?
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.
Does This Change Need a New 510(k), or Does a PCCP Cover It?
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).
Is This Reagent an ASR or a Finished IVD?
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.
Does This US IVD Study Need an IDE, an IND, or Neither?
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.
Which Combination-Product 4.4 Path Still Applies After QMSR?
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.
Combination Product Safety Reports: Which Clock, Which System, Which Applicant?
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.
Changing Device Distributors: Who Keeps Complaint and Traceability Files?
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.
Device Label Translation: Reconciling Units, Symbols, and Released Versions
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.
Incomplete Supplier Change Notices: A Device QA Triage Guide
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.
MedDeviceRepair: Keeping Loaner Exchanges Traceable When Serial Numbers Change
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.
Outsourced Device Testing: What Raw Data Must Your Contract Deliver?
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.
VetMedGuide: Building a Useful Veterinary Device Field-Feedback Form
A manufacturer intake worksheet for veterinary analyzer complaints: separate instrument observation, species and matrix, clinic QC evidence, and unsupported causality.
NMPA GMP Announcement 107: Dual Release, Key-Person Gates, and the 1 November 2026 Clock
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.
EClinCloud EDC for Device Studies: Linking Versions, Deficiencies and Endpoints
Evaluate whether a configurable EDC study build can reconstruct device models, firmware versions, deficiencies, and endpoint records for FDA and EU MDR trials.
HSA GN-21 R7 Change Notification: 6Aii/6Aiii Approval, Two-CN Cap, & August Clock
Singapore HSA GN-21 Revision 7 change notification guide: when 6Aii/6Aiii SMDR updates require approval, the two-active-CN cap, and the 1 August 2026 clock.
FDA 2026 Container Closure Draft: Device-Constituent CCS, 510(k), & October Clock
FDA August 2026 container closure systems draft guidance: device-constituent CCS vs packaging, 510(k)/PMA vs NDA, Section V.B.3, and Docket FDA-2026-D-7957.