Book a Medical Device Label & UDI Compliance Check

Book a medical device label and UDI compliance quick check online. Compare vetted EU MDR, IVDR, and FDA UDI specialists with instant per-label pricing.

✓ 10 active providers available right now · USD 390 – 1,013

Why this page is different

  • Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
  • Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
  • Charged only when accepted: You are charged only after a provider accepts your order and scope.
  • Live availability: 10 active providers available right now for this service.

What you can compare here

  • Total price: See live price ranges and instant pricing rules where available.
  • Coverage & scope: Markets served, what is included, and what is explicitly excluded.
  • SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
  • Add-ons: Optional extras you can book next (shown as add-on chips).
  • Onboarding time: How quickly providers can start and what you need to supply.

Compare providers (instant pricing + book)

Provider Estimated base price Accept SLA Turnaround Start
Northgate Regulatory Partners USD 390 24h 3–5 days Within 2 business days
Sterling Label & Compliance USD 619 24h 3–5 days Within 2 business days
Apex Medical Device Support USD 945 24h 3–5 days Within 2 business days
Belmont Regulatory Services USD 619 24h 3–5 days Within 2 business days
Summit Device Compliance USD 945 24h 3–5 days Within 2 business days
Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

  • skuCount (Required)
    min 1
  • markets (Required)
    min 1
  • assetCount (Required)
    min 1
  • languages (Required)
    min 1
  • revisionRounds (Required)
    min 1
  • packagingLevelsCount (Required)
    min 0
  • udiDepth (Required)
    basic|standard|deep
  • deviceClass (Required)
    I|II|III
  • layoutComplexity (Required)
    simple|normal|complex
  • turnaround (Required)
    standard|rush_48h|rush_24h
  • sterile (Optional)
  • implantable (Optional)
  • combinationProduct (Optional)
  • softwareSaMd (Optional)
🏥
Scope
EU MDR · IVDR · FDA
🔍
Output
Non-conformity report
⚡
Turnaround
1–5 business days
💰
Pricing
Per label / per SKU

How it works

  1. 1
    Upload your label and specify the regulation
    Submit your current device label and select the applicable regulation (EU MDR, IVDR, FDA 21 CFR 801, or combined).
  2. 2
    Compare UDI/label specialists
    View per-label fees and turnaround from reviewers experienced in UDI-DI/UDI-PI requirements and regulatory labelling standards.
  3. 3
    Receive your non-conformity report
    Your reviewer identifies gaps, UDI placement issues, and mandatory symbol requirements with actionable fix instructions.

What must a medical device label contain under EU MDR?

EU MDR 2017/745 Annex I Chapter III specifies the labelling requirements for CE-marked medical devices. Mandatory elements include: the manufacturer's name and address; the EC REP's name and address (for non-EU manufacturers); a clear and unambiguous identification of the device and its version; the intended purpose summary where necessary for safe use; "sterile" designation and sterilization method code (if applicable); any warnings or precautions; the Unique Device Identifier (UDI-DI) in both human-readable and machine-readable form; single-use labelling (if applicable); date of manufacture or expiry; and the CE mark with notified body number for Class IIa, IIb, and III devices. Omitting any mandatory element is a non-conformance that can block market access.

UDI requirements: what you need on the label

The Unique Device Identifier (UDI) consists of two components: the UDI-DI (Device Identifier — static, identifies the device version and labelling) and the UDI-PI (Production Identifier — dynamic, identifies the specific production unit including lot/batch, serial number, manufacturing date, or expiry date). Under EU MDR, the UDI must appear on the label as a machine-readable barcode (DataMatrix recommended) plus a human-readable interpretation (HRI) directly below it. The UDI-DI must also be registered in EUDAMED. Under FDA UDI rules (21 CFR Part 830), the same components apply but are submitted to the GUDID database.

Common label non-conformities found in reviews

The most frequently identified label failures in professional reviews include: incorrect INCI nomenclature or ordering on cosmetic labels (which affects cosmetics, not medical devices, but the same concepts apply); missing mandatory ISO symbols; UDI barcode placed on the wrong packaging tier; HRI missing below the DataMatrix; non-EU EC REP address missing or incomplete; ambiguous intended purpose statements for borderline products; incompatible font size or contrast for mandatory warnings; and missing language versions for multi-country EU distribution. A professional label review catches all of these before your products go to market or before an audit.

FDA labelling requirements under 21 CFR Part 801

FDA medical device labelling requirements under 21 CFR Part 801 mandate the following on device labels: manufacturer name and address, device identity and adequate directions for use (or exemption), quantity of contents, and any required warnings. For UDI specifically, FDA 21 CFR Part 830 requires the UDI to appear on the label (and packaging) in both plain text and AIDC (automatic identification and data capture) format. Device-specific regulations (e.g., 21 CFR 880 for general hospital devices) may add further requirements. FDA labelling non-compliance is one of the most common 483 observation categories.

Frequently asked questions

What regulations does a medical device label check cover?
Providers on Cruxi Bridge can review against EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 801, and UKCA labelling requirements, depending on the provider's expertise and your scope.
Is a UDI check included in the label review?
Yes — the "UDI Quick Check" specifically verifies that your UDI-DI (device identifier) and UDI-PI (production identifier) meet placement, format, and encoding requirements for your target market.
What is the UDI Carrier and where does it appear on the label?
The UDI Carrier can be a linear barcode, 2D DataMatrix, or RFID tag. Under EU MDR and FDA rules, the human-readable interpretation (HRI) must accompany the machine-readable form on the label or packaging.
How often should I re-review my device labels?
Re-review when your device design, IFU, indications, software version, or labelling claims change, or when a new regulation update introduces new labelling requirements.

How Cruxi Bridge vets providers

  • ✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
  • ✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
  • ✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
  • ✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms

Prices and provider availability are live and may change. Charged only when a provider accepts your order. ← All services

Cruxi - Regulatory Compliance Services