Blockchain Development for Healthcare Supply Chains: Tracking Drugs and Devices

Healthcare supply chains are entering a hard compliance window. This guide shows decision‑makers how to use blockchain alongside GS1 EPCIS, VRS, and UDI/EUDAMED to meet near‑term U.S. DSCSA and EU MDR/IVDR deadlines while delivering verifiable tracking for drugs and devices.

— Summary: By anchoring EPCIS event streams, ATP credentials, and device UDI master data to a permissioned ledger (with selective public anchoring), organizations can prove traceability without exposing sensitive data, accelerate recalls, and pass audits for DSCSA (2025+) and EUDAMED (from May 28, 2026).

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Why now: the regulatory clock just advanced

• United States (Drugs, DSCSA)

  • FDA’s “stabilization period” for the DSCSA enhanced, electronic, package‑level tracing ended on November 27, 2024. FDA granted targeted exemptions beyond that date to prevent disruptions: manufacturers/repackagers until May 27, 2025; wholesale distributors until August 27, 2025; dispensers with ≥26 staff until November 27, 2025; small dispensers until November 27, 2026. If you used the exemptions, you still must show progress and be ready to flip to fully interoperable exchange. (fda.gov)
  • FDA’s final guidances clarify what “enhanced drug distribution security” means in practice (e.g., verifying product identifiers, tracing at package level, responding fast to trace and verification requests). (fda.gov)
  • Industry bodies (PDG/HDA) have published blueprints, exception handling, and VRS governance to get trading partners live and interoperable. (dscsagovernance.org)

• European Union (Devices, MDR/IVDR)

  • The European Commission declared the first four EUDAMED modules fully functional on November 27, 2025, triggering a six‑month transition. As of May 28, 2026, Actor Registration, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance become mandatory to use; Vigilance and Clinical Investigations/Performance Studies will follow later. (health.ec.europa.eu)
  • UDI label placement deadlines continue to run (e.g., MDR Class I devices labeling since May 26, 2025), and EUDAMED registration deadlines for legacy devices kick in by November 27, 2026. (webgate.ec.europa.eu)

• Global trendlines

  • U.S. hospitals and regulators are increasing use of product verification services (VRS) to investigate suspect products; Arkansas verified a suspect Ozempic lot within days in January 2025 via NABP Pulse PVS. (nabp.pharmacy)
  • India restructured its export traceability policy in 2025 (DGFT withdrawal of export track‑and‑trace rule), while pursuing domestic barcode expansions and pharmacy QR codes for ADR reporting—illustrating the patchwork global picture your systems must accommodate. (economictimes.indiatimes.com)

Bottom line: 2025–2026 is the period when auditors and regulators will expect operational interoperability. Blockchain can provide the auditability glue without replacing required DSCSA/EUDAMED data rails.

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What blockchain adds (and what it shouldn’t replace)

Blockchain is not a replacement for GS1 standards, EPCIS repositories, or regulator portals. It strengthens them by providing:

• Proof of integrity for EPCIS events (commission, pack, ship, receive, de‑aggregate) via cryptographic anchoring and notarized timelines.
• Shared, tamper‑evident registries of Authorized Trading Partner (ATP) credentials and relationship attestations (based on OCI verifiable credentials), reducing manual license lookups. (oc-i.org)
• Non‑repudiation for VRS lookups/verification responses and regulator interactions (e.g., trace/verification requests via Pulse/NABP), while preserving data minimization. (nabp.pharmacy)
• Selective disclosure: prove you hold compliant TI/TS data for a lot/serial or that you responded within SLA, without exposing commercial or patient data.

It should not:

• Store EPCIS payloads, PHI, or commercial terms directly on-chain.
• Duplicate EUDAMED/GUDID master data; instead, it should anchor hashes and maintain link pointers.

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Standards you must align with (and how blockchain fits)

• GS1 EPCIS/CBV
  • EPCIS 2.0 adds JSON/JSON‑LD, REST capture/query, sensor telemetry for cold chain, and digital link URIs—a natural fit for modern microservices and IoT. Use on‑chain anchors for event batches (e.g., daily Merkle roots) to make traces auditable. (gs1.org)
• DSCSA Interoperability and VRS
  • Follow PDG’s 2023+ Blueprint and connection templates; design your chain services to reference EPCIS connection details and exception root‑cause taxonomies so that on‑chain attestations mirror PDG exceptions handling. (dscsagovernance.org)
  • For saleable returns and suspect product checks, integrate with HDA’s VRS Provider Network; record verification claims (request/response digests) on-chain for forensics. (hda.org)
• Authorized Trading Partner (ATP) credentials
  • Adopt OCI ATP credentials and automate license validation via services like Legisym; record credential issuance/revocation events to a permissioned chain to enable instant trust checks across systems. (ledgerdomain.com)
• Device UDI and EUDAMED
  • Maintain UDI master data in source systems and GUDID/EUDAMED; use the ledger to notarize device listings, certificate references, and market surveillance submissions entered by economic operators. (fda.gov)

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Reference architectures that work in 2025–2026

1. DSCSA drug tracing and verification

• Components

  • EPCIS 1.2/2.0 repository per org
  • VRS client and Lookup Directory connectivity
  • ATP credentialing (OCI) and license verification
  • Pulse/NABP integration for regulator and cross‑network requests
  • Permissioned blockchain (e.g., Hyperledger Fabric or enterprise EVM) with:
    • Channels for bilateral proofs (e.g., manufacturer–wholesaler)
    • Public L2 anchoring (periodic) for independent timestamping

• Flow (saleable return or suspect product)

  • Scan GS1 DataMatrix → VRS query routed to manufacturer responder → response signed and returned → on-chain writes: hash of request/response, ATP IDs, timestamp, SLA metric → off-chain EPCIS/ASN cross‑check to resolve misalignments per PDG guidelines. (hda.org)

• Why it passes audits

  • FDA expects timely verification/tracing and accurate product identifiers; your ledger provides immutable proof of response times and ATP status at the time of transaction. (fda.gov)

1. EU medical devices UDI/EUDAMED readiness

• Components

  • UDI master data management synchronized with EUDAMED UDI/Devices
  • Notified Body certificate registry references
  • Hospital point‑of‑care scanning (GS1 identifiers) and recall workflows
  • Permissioned blockchain for:
    • Anchoring device registration snapshots (hash of UDI/DEV records)
    • Recording regulator interactions (market surveillance case ids)
    • Optional anchoring of implant logs to support registries

• Flow (UDI registration and recall)

  • Manufacturer registers device and uploads to EUDAMED → ledger records hash of record, SRN, and certificate reference at submission time → if a Field Safety Corrective Action occurs, hospital inventory scans are reconciled against ledger‑anchored UDI snapshots to prove notification/segregation timing. (health.ec.europa.eu)

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Practical examples with fresh industry context

• Product verification at scale

  • NABP’s Pulse PVS (built from MediLedger PVS) is now used by regulators in 20+ U.S. states and DEA field offices; boards used it in January 2025 to validate suspect semaglutide (Ozempic). A blockchain layer can notarize those verification transactions across networks, reducing dispute resolution time. (nabp.pharmacy)

• EPCIS 2.0 with sensor telemetry for biologics

  • EPCIS 2.0 natively carries temperature/humidity telemetry and JSON‑LD. We see teams batching event digests hourly for ultra‑cold shipments (−70°C), anchoring to a Fabric channel, and publishing a daily root to a low‑cost L2. This gives investigators cryptographic assurance that the entire cold‑chain story is intact—without revealing raw sensor streams. (gs1.org)

• VRS governance alignment

  • HDA’s VRS Provider Network codified request/response messaging and lookup directory synchronization. Recording lookup directory state changes (responder CI, certificates) on-chain prevents “stale directory” failures during audits. (hda.org)

• EU EUDAMED go‑live sequencing

  • With Decision (EU) 2025/2371, the first four modules become mandatory from May 28, 2026, with six months to prepare. Teams are creating “EUDAMED proof packs” (SRN evidence, UDI completeness checks) and hashing them to a consortium ledger to demonstrate readiness across affiliates before regulator spot checks. (health.ec.europa.eu)

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Best emerging practices we recommend (with specifics)

• Use EPCIS 2.0 now, even if partners are on 1.2

  • Leverage GS1’s EPCIS Sandbox to convert between 1.2 and 2.x and to validate event vocabularies. Keep repositories in 2.0 internally; expose 1.2 to partners that aren’t ready. (gs1.org)

• Treat blockchain as an attestation and policy plane

  • Store hashes, credentials, and policy outcomes—not payloads. For every outbound EPCIS transmission, write an on‑chain attestation: who sent what (hash), to whom (ATP ID), when, and why (business step, disposition). This gives auditors a provable envelope.

• Adopt OCI verifiable credentials for ATP checks

  • Issue/verify ATP credentials via OCI and record credential lifecycle events (issue/suspend/revoke) to the ledger to avoid email‑based license chases and screen shots during investigations. (oc-i.org)

• Capture VRS verifications on-chain

  • Extend your VRS client to emit signed “verification claims” (request id, responder id, result, response hash). During a suspect product or diversion investigation, those claims drastically shorten root cause analysis. (hda.org)

• Pre‑build DSCSA exceptions playbooks

  • Codify PDG/HDA exception categories (e.g., serial misalignment, aggregation breaks) into smart‑contract enums to consistently record exception openings/closures and SLAs. (dscsagovernance.org)

• For devices, build a UDI “golden record” with ledger proofs

  • UDI master data quality is an FDA priority; hash snapshots of your UDI datasets to establish provenance from engineering change to EUDAMED/GUDID submission. Include SRN, DI, PI semantics, and certificate references. (fda.gov)

• Plan for EUDAMED’s staggered mandate

  • Map your obligations to the four mandatory modules in 2026 and the two to follow. Create internal “EUDAMED Day‑1 Readiness” attestations (actors registered, UDI fields complete, NB certificates uploaded) and anchor them quarterly. (health.ec.europa.eu)

• Prove chain of custody for cold chain

  • Use EPCIS sensor extensions to capture excursions. Batch to on‑chain every hour for high‑value biologics; daily for small molecule lines. Maintain Merkle trees per lane to localize data exposure to “need‑to‑know.” (gs1.org)

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Implementation blueprint (what we deliver in 12–20 weeks)

• Weeks 1–3: Readiness and design

  • DSCSA/EUDAMED gap assessment (by product family, lane, and market).
  • Event taxonomy mapping to EPCIS 2.0; partner capability matrix (1.2 vs 2.0).
  • Choose ledger fabric (Fabric vs enterprise EVM) and anchoring cadence.

• Weeks 4–8: Build the “attestation spine”

  • Deploy permissioned ledger; establish channels and ACLs.
  • Implement EPCIS hash anchoring and verification claim smart contracts.
  • Integrate ATP credentialing (OCI) and license verification.

• Weeks 9–12: Interop and VRS

  • Connect VRS client; record verification claims and directory state proofs.
  • Pilot with two trading partners and one regulator workflow (Pulse PVS where applicable). (pulse.pharmacy)

• Weeks 13–20: Device/UDI and EUDAMED prep

  • UDI golden record hashing; SRN proof bundle; Notified Body certificate references.
  • Simulated recall drill: demonstrate end‑to‑end identification and quarantine within SLA; notarize outcomes against EUDAMED timeline. (health.ec.europa.eu)

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Data model and volume planning (realistic numbers)

• Mid‑size pharma (10M saleable units/year)

  • Expect 4–6 EPCIS events per unit across commissioning, packing, shipping, receiving, and de‑aggregation: ~50M events/year.
  • Do not write raw events on-chain. Write one attestation per batch (e.g., 10k events) with a Merkle root: ~5k on‑chain writes/year per lane—manageable even on conservative Fabric/EVM configs.

• Device manufacturer (50k SKUs, multi‑market)

  • UDI master records hashed quarterly; expected on‑chain writes: 200–400/quarter including certificate updates and actor profile changes.

• Verification activity

  • For returns/suspect checks, assume 0.3–0.8% of inbound cases require VRS; notarize only those. HDA’s VRS PN governance provides stable request/response semantics. (hda.org)

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Privacy, security, and auditability

• Never write PHI or pricing to chain. DSCSA and UDI flows don’t require PHI; keep payloads in EPCIS/GUDID/EUDAMED and internal systems.
• Use per‑relationship channels or private data collections to segregate sensitive attestations (e.g., direct‑to‑pharmacy pricing events).
• Consider optional public anchoring (daily) on a low‑cost L2 to establish independent timestamps without leaking business data.

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KPIs to prove value beyond compliance

• DSCSA verification response SLA: ≥99% within 1 minute (auditable via on‑chain claims). (fda.gov)
• Exception mean time to resolution: −40% after codifying PDG categories and using notarized envelopes. (dscsagovernance.org)
• Recall time for devices: reduce to hours by reconciling point‑of‑care scans (GS1) against ledger‑anchored UDI snapshots; align with EUDAMED market surveillance workflows. (health.ec.europa.eu)
• Interop coverage: ≥90% partners exchanging EPCIS (1.2/2.0) with conversion/validation via GS1 tools. (gs1.org)

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Tooling and vendor ecosystem signals

• EPCIS and conformance
  • GS1 provides an EPCIS 2.0 Sandbox and conversion tools; several solution providers have attained GS1 US EPCIS conformance trustmarks (e.g., TraceLink’s 16 trustmarks across manufacturer→wholesaler→dispenser flows). (gs1.org)
• VRS maturity
  • HDA’s VRS Provider Network codifies governance, lookup directories, and request/response messaging; align your implementation to its artifacts to reduce edge‑case failures. (hda.org)
• Regulator networks
  • Pulse by NABP connects regulators and trading partners with ATP profiles, VRS, and trace workflows; integrate via APIs to simplify DSCSA communications and demonstrate readiness. (pulse.pharmacy)

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Pitfalls to avoid

• Storing payloads on-chain (creates GDPR, IP, and scale problems).
• Skipping exception taxonomy: without PDG/HDA categories, you can’t compare performance across partners. (dscsagovernance.org)
• Treating blockchain as “the” traceability system: regulators want EPCIS, UDI, and EUDAMED/GUDID compliance first; blockchain is the audit/assurance layer. (fda.gov)
• Ignoring device timelines: the first four EUDAMED modules become mandatory May 28, 2026; vigilance/clinical modules will follow with no voluntary period. Design your data model now to avoid rework. (health.ec.europa.eu)

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What great looks like in 2026

• Every serialized drug transaction has an EPCIS trail, a VRS‑verifiable product identifier, and an immutable attestation of “who/what/when” for audits.
• Every device has UDI master data aligned across PLM/ERP/labeling and registered in EUDAMED/GUDID; your ledger shows when records were registered/updated and who attested.
• Regulators can request verification/trace in hours, and your systems respond with proofs—not PDFs.

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How 7Block Labs can help

• DSCSA accelerator: PDG‑aligned data model, EPCIS 2.0 conversion/validation, VRS integration, ATP credentialing, and a Fabric/EVM attestation spine pre‑built.
• EUDAMED readiness kit: UDI golden record hashing, SRN/actor onboarding workflows, certificate reference anchoring, and recall drill playbooks.
• Architecture and TCO: anchoring cadence, node ops, SLA design, selective public anchoring, and zero‑trust integration patterns.

If you’re targeting DSCSA full operability in 2025 and EUDAMED mandatory modules by May 28, 2026, the window to industrialize is now.

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Sources

• FDA DSCSA stabilization period and exemptions beyond Nov 27, 2024; dates by partner type; guidance on enhanced drug distribution security and standards. (fda.gov)
• PDG Foundational Blueprint, workshops, and templates for DSCSA interoperability and exception handling. (dscsagovernance.org)
• HDA VRS Provider Network governance and role in saleable returns verification. (hda.org)
• NABP Pulse PVS adoption by regulators and platform features for ATP and VRS connectivity. (nabp.pharmacy)
• GS1 EPCIS/CBV 2.0 features and EPCIS Sandbox; EPCIS conformance trustmarks. (gs1.org)
• EU EUDAMED Decision (EU) 2025/2371 and May 28, 2026 mandatory modules; transition timelines and module scope. (health.ec.europa.eu)
• UDI label deadlines and U.S. UDI/GUDID program context and data quality emphasis. (webgate.ec.europa.eu)
• India policy shifts (DGFT 2025 withdrawal; pharmacy ADR QR). (economictimes.indiatimes.com)

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