Who We Serve: Business Model
Relabelers, Repackagers and Kit Assemblers
Relabeling a device, repackaging it or assembling it into a kit can look like a logistics step. Regulators treat it as manufacturing, and the firm that does it takes on registration, labeling, UDI and quality system duties for what it changed. We help relabelers, repackagers and kit assemblers see those duties clearly and build records that hold up.
Standards and Regulations to Know
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 830Unique Device Identification
- EU MDR (Regulation (EU) 2017/745)European Union Medical Device Regulation
- ISO 11607Packaging for Terminally Sterilized Medical Devices
- ISO 11135Ethylene Oxide Sterilization
- ISO 15223-1Symbols for Medical Device Labeling
- ISO 13485Quality Management Systems for Medical Devices
Typical Regulatory Exposure
FDA's registration rules cover anyone who repackages or relabels a device (21 CFR 807.20(a)(3)), and the QMSR names relabeling and repacking among the functions of a manufacturer. That brings in the labeling and packaging controls in 820.45, UDI duties under 21 CFR 830 for the labeler, and complaint, reporting and correction and removal duties for the devices you changed. Adding only your name and contact details as distributor, with no other label changes, is not treated as a modification for UDI labeler purposes, so check the definitions in 21 CFR 801.3.
FDA's Convenience Kits Interim Regulatory Guidance (1997) describes kits of legally marketed devices assembled for the user's convenience, and explains that kit assemblers still register, list and follow good manufacturing practices. Whether a kit needs its own 510(k) depends on the components and on what the assembler does to them; sterilizing the kit, changing components or adding components that are not legally marketed changes the analysis. Devices packaged inside a convenience kit can rely on the kit's UDI rather than their own, provided the kit label bears one.
In the EU, MDR Article 16 lets importers and distributors translate information and change outer packaging without becoming manufacturers, but only under conditions, including a quality management system certified by a notified body and notice to the manufacturer and competent authority at least 28 days in advance. Opening or damaging sterile packaging is presumed to affect the device's original condition. Article 22 covers systems and procedure packs: the person who combines CE marked devices draws up a statement, a person who sterilizes the pack follows a conformity assessment limited to sterility, and a pack outside those conditions is treated as a device in its own right.
Where Audits Find Gaps
- 01
Label Changes Outside Change Control
Label artwork, translations or private-label versions are updated by marketing or customer request without going through document and change control.
- 02
Line Clearance Not Documented
Relabeling and repackaging runs switch between products without recorded line clearance and label reconciliation, the classic source of mixups.
- 03
Component Swaps Not Assessed
A kit component was replaced with a different brand or model without checking that it is legally marketed and compatible with the rest of the kit and its labeling.
- 04
Kit Sterilization Without Compatibility Evidence
The kit is sterilized as a whole, but there is no evidence that each component, including those already sterile, tolerates the process.
- 05
Upstream Recalls Not Traced Into Kits
When a component maker issues a recall, the firm cannot tell quickly which kit lots contain the affected component lots.
- 06
Kit Expiry Ignores the Shortest Component
The kit's labeled expiration date does not account for the component with the shortest remaining shelf life.
Relevant Standards and Regulations
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 830Unique Device Identification
- EU MDR (Regulation (EU) 2017/745)European Union Medical Device Regulation
- ISO 11607Packaging for Terminally Sterilized Medical Devices
- ISO 11135Ethylene Oxide Sterilization
- ISO 15223-1Symbols for Medical Device Labeling
- ISO 13485Quality Management Systems for Medical Devices
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
EU Notified Body Audit (Including Unannounced Audits)
Conformity assessment, surveillance and unannounced audits by an EU notified body under the MDR or IVDR.
Customer Audit
A customer's audit of your quality system, often a device maker auditing a supplier or contract manufacturer.
Questions
Does a convenience kit need its own 510(k)?
Not always. FDA's convenience kit guidance describes kits of legally marketed components, bought in finished form and not processed in ways that significantly affect safety or effectiveness, as generally not needing a new 510(k). Sterilizing the kit, changing components or adding new claims can change that, so document your determination for each kit.
Who is responsible for the UDI on a relabeled device?
The labeler, which under 21 CFR 801.3 includes a person who replaces or modifies a device label for commercial distribution. Adding only your name and contact details as distributor is not treated as a modification for that purpose. A new device package also needs its own device identifier.
Can a distributor repackage devices in the EU without becoming the manufacturer?
Under MDR Article 16, yes, within limits. The repackaging must be needed to market the device in that Member State and must not affect its original condition, and the distributor needs a quality management system certified by a notified body and must notify the manufacturer and competent authority at least 28 days in advance. Opening sterile packaging is presumed to affect the original condition.
Relabelers, Repackagers and Kit Assemblers
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