MDR 2017/745 broadened the responsibilities of distributors. Which documents and processes should hospitals look for in a supplier?
The European Union Medical Device Regulation (MDR 2017/745) defines the obligations of importers and distributors in far more detail than the old directives, alongside those of manufacturers. Because medical device legislation in Türkiye is aligned with this framework, hospital purchasing and biomedical units should check how a distributor meets these obligations when choosing a supplier.
The distributor's core duties
Before placing a product on the market, a distributor checks that the CE mark, declaration of conformity and Turkish label and instructions for use are present. It must be verified that the product is registered in UTS, that the record matches the product and that UDI data is entered correctly. If a suspected nonconformity is noticed, not offering the product for sale and notifying the manufacturer is a legal duty.
Storage and transport conditions
A distributor must ensure storage and transport conditions that do not compromise conformity. Temperature and humidity records, FEFO practice, a separate quarantine zone and a recall procedure are the principal records requested in audits.
Traceability and complaint handling
It must be possible to show, by serial and lot number, which product went to which customer. Reaching affected customers quickly in a recall or field safety notice depends on this. Complaints must be recorded, assessed and, where necessary, forwarded to the manufacturer.
A checklist for hospitals
- Does the supplier hold ISO 13485 or an equivalent quality certificate?
- Are the sales centre and warehouse permits current?
- Does the quotation give UTS registration numbers for the products?
- Are Turkish instructions for use and training material part of delivery?
- Is there a defined communication channel for materiovigilance reports?
- Are service and spare parts supply times committed in writing?
When the answers to these questions are added to the technical specification, a tender can be assessed in a way that neither restricts competition nor compromises patient safety. At Hemera Medikal we share this document set with all our quotations.
Common mistakes
The problems met most often in practice are these: using a product with no UTS record or one made for a different model, delivering the Turkish instructions for use incompletely, not keeping storage temperature records, and being unable to reach the customer list quickly in a recall. These mistakes carry the risk of administrative sanctions and can directly affect patient safety.
Hemera Medikal's approach
A document checklist is completed for every incoming shipment, the product is queried in UTS and released for sale only after conformity is verified. Every delivery note sent to a customer carries a serial or lot number. Our quality unit carries out a recall drill once a year and reviews the result in management review.
Conclusion
Regulatory compliance is not merely a pile of documents but a process repeated with every shipment. A reliable distributor should be able to show this process transparently.