An SLA and an exclusivity arrangement are two separate documents doing two different jobs, and distributors who treat them as one package usually discover the difference after signature. The service-level agreement sets the operating rhythm: response windows, complaint handling, delivery performance, audit access. The exclusivity clause sets the commercial boundary: territory, category scope, volume commitments, renewal and exit. If you are comparing supplier terms before signing, this post gives you the evaluation frame in three parts: what is standard, what is negotiable, and what the regulation fixes regardless of what the contract says.
Key Takeaways
An SLA and an exclusivity clause are negotiated separately; one governs service performance, the other governs market rights.
Regulation fixes reporting clocks, not response times: EU MDR Article 87 sets 2, 10 and 15 calendar days for serious incidents, and 21 CFR 803 sets 30 calendar days and 5 work days for US adverse-event reports.
Every business-day figure for complaint acknowledgement, triage or CAPA containment is a contract term, not a regulatory requirement.
SLK Medical SLA and exclusivity: what each document actually covers
Medical device supplier SLA terms describe service performance, while an exclusivity clause describes market rights, and the two are negotiated on different evidence. The SLA should name the metric, the measurement basis and the clock: bulk order lead time, complaint acknowledgement, complaint triage, CAPA containment, audit-document retrieval and OTIF. Under the FDA quality management system regulation, a manufacturer must document a quality management system complying with ISO 13485, and the clause that links complaints to FDA reporting requires notification of complaints meeting Part 803 criteria (21 CFR 820.10, codified text). Complaint records must carry the complaint record fields the QMSR requires, including device name, receipt date, UDI or UPC, complainant details, nature of the complaint, corrective action and any reply (21 CFR 820.35, codified text). Those fields tell you what a supplier can actually retrieve on request, which is the practical test of an audit-access clause.
Term | Usually standard | Usually negotiable |
|---|---|---|
Complaint acknowledgement | Defined window | Length of window, escalation path |
Complaint triage | Defined window | Severity bands, who classifies |
CAPA containment | Defined window | Trigger thresholds, reporting format |
Bulk order lead time | Stated capability | Committed lead time, remedies for misses |
Audit-document retrieval | Access right | Retrieval time, format, frequency |
OTIF | Pass/fail per order | Measurement basis, partial shipments, substitutions |
The scorecard rows above are an example structure, not a published benchmark. No SLK document sets exclusivity terms, so treat exclusivity structure as a negotiation, not a published policy. For the commercial side of the same package, the SLA, MOQ and lead-time checklist covers the terms distributors most often leave undefined.
Which SLA metrics matter most, and how is OTIF defined
OTIF has no single authoritative definition, so the metric is only as useful as the measurement basis written beside it. Ask whether on-time is measured against the requested delivery date or the ship date, whether complete is measured per purchase-order line, per shipment or per SKU, and how partial shipments and substitutions are counted. The widely repeated targets of roughly 95% OTIF and 98 to 100% fill rate appear in vendor material and example scorecards without a published dataset, so treat them as illustrative rather than as an industry standard. Regulatory clocks are the one place where the numbers are fixed: EU MDR Article 87 sets the 2, 10 and 15-day vigilance windows, counted in calendar days from the manufacturer’s awareness date (Medfortis, updated 1 July 2026). In the US, an individual adverse-event report is due no later than 30 calendar days after awareness, and a 5 work-day report applies where the event necessitates remedial action to prevent an unreasonable risk of substantial harm to public health (21 CFR Part 803, current eCFR text). Note the unit difference: EU clocks are calendar days, the US 5-day clock is work days. Lane-by-lane evidence of how on-time and complete are actually measured is set out in the lane-specific OTIF proofs.
What the regulation fixes, and what the contract has to fix
Regulation fixes reporting clocks and post-market duties; it does not fix CAPA or complaint response timelines, which is why those belong in the SLA. The Commission’s own vigilance guidance defines a serious incident as any incident that directly or indirectly led, might have led or might lead to death, temporary or permanent serious deterioration of health, or a serious public health threat (MDCG 2023-3 Rev. 2, January 2025). The manufacturer’s post-market surveillance duty under MDR Article 83 requires a system planned and maintained for each device, proportionate to risk class, and forming an integral part of the quality management system (legislation.gov.uk, Regulation (EU) 2017/745). Article 84 requires a documented PMS plan as part of the technical documentation, Article 85 gives the Class I PMS report, and Article 86 requires a PSUR for higher classes (Medfortis, updated 1 July 2026). Neither the QMSR nor MDR Articles 83 to 87 sets a numeric CAPA or complaint-response deadline, so any business-day figure in your CAPA and complaint response timelines is a negotiated term. What you can verify instead is scope: the ISO 13485 scope SLK is certified for covers design, development, production and distribution of sterile polyurethane, gelling fiber and super absorbent dressings, plus production and distribution of sterile foam, transparent, waterproof, hydrocolloid, alginate and silicone absorbent fiber dressings at the Tianchang facility. The regulatory proofs checklist shows how to verify that scope against the certificate itself.
The day counts quoted here are framework ranges. The binding numbers are set per agreement, and nothing in this article is legal advice.
What should tender support and exclusivity negotiation include
Tender support and exclusivity negotiation come down to two questions: what documentation you can put in a bid, and what you receive in exchange for a market commitment. For the bid, ask for the current certificate and its scope, the declaration of conformity and its applied standards, the instructions for use, and a sampling plan with lead times. Certification runs on the standard three-year certification cycle, with surveillance audits in years 1 and 2 and recertification in year 3, a rhythm set by ISO/IEC 17021-1 rather than by ISO 13485 itself (Greenlight Guru, 18 August 2026). That cycle matters because a certificate approaching recertification is a different procurement risk from one issued months ago. For a wound dressing distributor exclusivity agreement, treat exclusivity as a trade rather than a grant: territory and category scope against minimum purchase commitments, performance gates, and renewal or exit rights. No sector-specific primary source for distributor exclusivity terms was found, so the questions below are the framework, not a market norm.
Does exclusivity cover the whole category or named SKUs only?
What volume or revenue gate must be met, measured over what period?
What happens to exclusivity if the gate is missed: renegotiation, conversion to non-exclusive, or termination?
What are the renewal terms, and on what notice?
What documentation and sampling support is committed for tenders?
What are the exit terms, including run-off stock?
The post-award support checklist sets out the governance cadence that keeps those commitments measurable after signature.
Frequently Asked Questions
How long does a standard medical device supplier agreement run, and what triggers renewal?
Most supplier agreements run for a fixed initial term with renewal by notice or by mutual written agreement, and the renewal mechanics matter more than the length. Ask whether renewal is automatic unless either party gives notice, and how many days of notice are required. The certification side runs on a separate clock: ISO 13485 certificates are valid for three years, with surveillance audits in years 1 and 2 and recertification in year 3 (Greenlight Guru, 18 August 2026). Aligning your contract term with the supplier’s certification cycle avoids signing a multi-year deal that spans a recertification you have not assessed.
Can exclusivity be limited to specific SKUs rather than a whole category?
Yes, and SKU-level exclusivity is usually the safer structure for a first agreement. Category-wide exclusivity commits the supplier to turn away other distributors across every product line, which they will price into minimum purchase commitments. SKU-level exclusivity lets you prove demand on the items you actually sell before widening the scope. Define the SKUs by reference number and size, and state what happens when a supplier discontinues or replaces a listed SKU.
What happens to exclusivity if volume commitments are missed?
The consequence should be written into the clause rather than left to a later discussion. Typical structures are conversion to non-exclusive status, a cure period before any change, or renegotiation of the territory. Ask for a defined measurement period, a defined cure window, and a defined remedy, and check whether the gate is measured on purchase orders placed or on units delivered, since those two numbers diverge when lead times slip.
Can a distributor hold ISO 13485 or MDR obligations of its own?
A distributor’s obligations differ from a manufacturer’s, and the two should not be conflated in the contract. Under the QMSR, the manufacturer must document a quality management system complying with ISO 13485 and notify FDA of complaints meeting Part 803 reporting criteria (21 CFR 820.10, codified text). The clause that links complaints to FDA reporting sits with the manufacturer, but your complaint records still feed it, so agree the format and the transmission window in the SLA.
How quickly must a supplier respond to a quality complaint when the contract is silent?
When the contract is silent, there is no fixed answer: neither the QMSR nor MDR Articles 83 to 87 sets a numeric complaint-response deadline. The US reporting clock is 30 calendar days for an individual adverse-event report, with a 5 work-day report where remedial action is needed to prevent an unreasonable risk of substantial harm to public health (21 CFR Part 803, current eCFR text). That clock runs from the manufacturer’s awareness, so a slow acknowledgement from your side can compress it. Write an acknowledgement and triage window into the SLA rather than relying on the regulation.
Conclusion
Before you sign, separate the two documents and test each on its own terms. The SLA should name every metric, its measurement basis and its clock, and you should be able to point to the record fields a supplier can retrieve when you ask. Exclusivity should be written as a trade with defined scope, gates, cure periods and exit terms, not as a general promise of territory. The regulatory floor is narrower than most distributors assume: it fixes reporting clocks and post-market duties, and it leaves response and retrieval times to the contract. The next step is a documentation ask rather than a purchase decision: request the current certificate and scope, the declaration of conformity, the instructions for use, the certifications pack and a sampling plan, then read them against the terms you are being asked to sign.
About the publisher. SLK Medical is a manufacturer of advanced wound care dressings, including silicone foam and silver dressings, and holds ISO 13485 and EU MDR QMS certification. It has a commercial interest in the wound care market, so weigh its perspective accordingly. The guidance above does not depend on its products.
