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gatePharmaMedical — Pharma & Medical Device Compliance Gate
// IMMO.QUICK · GATEPHARMAMEDICAL · MDR 2017/745 · AMG · EU-FMD 2011/62 · GMP

No warranty token, no batch release.

gatePharmaMedical forensically seals that a medical device or medicinal product passes four clusters, MDR CE & notified body, batch & GMP/QP, anti-counterfeiting & serialisation, and marketing authorisation & pharmacovigilance, before physical delivery. Support for manufacturers and authorities, never a replacement for a regulator's own recognition as evidence.

Request Access → See the architecture
In one sentence: gatePharmaMedical checks every batch against CE conformity, QP release, anti-counterfeiting, and marketing-authorisation duties, and makes the warranty token the mandatory cryptographic prerequisite for any physical release.
✓ RELEVANT IF...
  • You place medical devices or medicinal products on the market in the EU
  • You need to bind batch release to a cryptographic warranty token
✕ NOT RELEVANT IF...
  • You expect a notified body to automatically recognise the result as CE certification
  • No medical device or medicinal product is involved
// The problem

An expired certificate means illegal placing on the market.

The production of medical technology and pharmaceuticals requires seamless forensic compliance. gatePharmaMedical enforces the delivery stop fully automatically, no soft decisions, only PASS or BLOCK.

Up to 15 years imprisonment
§95 AMG and the MPG threaten up to three years imprisonment for placing products on the market without authorisation or a warranty token, up to five years in case of bodily harm, and up to fifteen years in case of death, directed personally at the responsible qualified person and management.
// Architecture

Four clusters, checked sequentially.

Every cluster is dispositive (material_block_mode: true), a hit blocks bindingly, not merely for documentation. That is the default in these C-level prison industries.

CLUSTER 1
MDR-CE & Notified Body
Checks CE marking, notified-body number (format NB####), and risk class (I, Is, Im, IIa, IIb, III) for validity.
ce_notified_body_id · risk_class · certificate_valid_until
CLUSTER 2
Batch & GMP/QP
Checks the qualified-person release signature, the GMP certificate, and the batch record hash. The warranty-token hash is the cryptographic prerequisite for any physical release.
qp_release_signature · gmp_certificate_valid · warranty_token_hash
CLUSTER 3
Anti-Counterfeiting & Serialisation
Checks the unique identifier against the EMVO verification system and the tamper-evidence of the packaging under delegated Regulation (EU) 2016/161.
unique_identifier_verified · tamper_evidence_intact
CLUSTER 4
Marketing Authorisation & Pharmacovigilance
Checks the marketing authorisation number and validity under §21 AMG, and timely adverse-event reporting to EUDRAVigilance within 15 days.
marketing_auth_number · auth_valid_until · adr_reported_within_15d
Fatal test case: medical device without a warranty token
A risk-class IIb medical device without a warranty token triggers BLOCK_P2_WARRANTY_TOKEN_MISSING, physical delivery of the batch is stopped. The warranty token is not a nice-to-have, it is the cryptographic bridge between the check and the physical movement of the product.
// Test results

Two tested scenarios.

All values on this page are fictional test data and serve only to illustrate the gate logic.

Scenario C1C2C3C4 Verdict Latency
BAYER Pharmaceutical, MDR risk III, QP+GMP+FMD OK, warranty token OK, AMG §21 OKPASSPASSPASSPASSPHARMA_MEDICAL_SEALED447ms
MERCK medical device without warranty tokenPASSFAILnot evaluatednot evaluatedBLOCK_P2_WARRANTY_TOKEN_MISSING733ms
Cryptographic chain continuation
Every test produces a deterministic receipt_id (VAR-PHRM-{TENANT}-{SEQ}), an input_snapshot_hash, an HMAC-SHA256 signature, and a merkle_link to the previous receipt. Persistence occurs in the PharmaMedicalReceipt entity with a 10-year retention period.
// Clarification

What gatePharmaMedical is not.

  • Not automatic recognition by a notified body or marketing-authorisation authority. The gate delivers a cryptographic proof, not CE certification.
  • Not an independent quality management system. The gate seals the release check, it does not replace an existing QMS.

For manufacturers and authorities that want to make batch releases provable.

Request Access → access@immoquick.eu
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