The situation
A company’s distribution and import role for each device line
Your company in Venlo has distributed a German manufacturer’s orthopaedic devices for years. From January it will also import a US manufacturer’s wound-care range and sell it in the Netherlands and Germany with Dutch and German labels it prints itself. The managing director asked what changes and who in the company has to do what.
The definitions are short. The hours go on applying them to each product line: when the company is a distributor, when an importer, and whether relabelling or its own name on the box makes it a manufacturer. Each role carries its own checks, records and reports, and the note has to assign them.
What the research has to settle
The rules behind the answer
- The role follows the activity
- Under the Medical Devices Regulation, a company that places a device from a third country on the EU market is the importer. A company that makes an already-placed device available further down the chain is a distributor. One company can hold both roles for different product lines.
- Importers verify before placing on the market
- An importer checks, among other things, that the device is CE marked with a declaration of conformity, that the manufacturer is identified and has an authorised representative, that the labelling and instructions are in order and that a UDI has been assigned. It adds its own name and address to the device, its packaging or an accompanying document.
- Distributors verify and keep records
- A distributor checks the CE marking, the declaration of conformity, the labelling and the importer’s details before making a device available, keeps to the storage and transport conditions, and keeps a register of complaints, non-conforming devices, recalls and withdrawals.
- Relabelling can make you the manufacturer
- Placing a device on the market under your own name, changing its intended purpose or modifying it in a way that affects compliance brings the manufacturer’s obligations. Translating labels or repackaging is carved out only under conditions, including advance notice and a certified quality system for those activities.
How it runs in azta
From the question to the document
The question, as you would type it
Dutch company. We distribute a German manufacturer’s devices, and from January will import a US manufacturer’s wound dressings and print our own Dutch and German labels. Under the MDR, what is our role for each line, what must we do, and does relabelling make us a manufacturer?
You start with
A company’s distribution and import role for each device line
- 01
Describe each product line
Name the manufacturers, where they are established and what you do with the product. azta searches the MDR and the Dutch and German implementing legislation.
Cited research· Free - 02
Check the national rules
Open the Dutch and German implementing provisions in the statute reader to see which authority supervises and what sanctions apply.
Atlas statute reader - 03
Draft the role and duty note
Ask for a note per product line: role, duties, owner and the record kept. Edit it in Canvas.
Canvas · Ask azta· Pro - 04
Export for the management team
Export to Word for sign-off and keep the cited research with the quality file.
Word export· Pro You send
An internal note on its MDR role, duties and owners per product line
What you get
An internal note on its MDR role, duties and owners per product line
Compliance note · draft
MDR roles and duties by product line
Orthopaedic devices from the German manufacturer. We act as distributor. Before each new device is made available we verify the CE marking, the declaration of conformity, the labelling and the importer details, and we keep the register of complaints and recalls. Owner: quality manager.
Wound-care range from the US manufacturer. We act as importer and must complete the importer checks before the first shipment, add our name and address and confirm the manufacturer’s authorised representative. Owner: regulatory affairs, with the warehouse responsible for storage conditions.
Our own labels. Printing translated labels is permitted only under the conditions for relabelling, including advance notice and a quality system certified for that activity. Until those are in place, we recommend using the manufacturer’s multilingual labels.
Outcomes on your numbers
What azta is worth on this task
Pro pays for itself after
15 minutes a month
At €110 an hour, that is all the time Pro (€27 a month) has to take off your desk to cover its price.
Example figures. Replace them with your own.
- Hours back a year
- 32
- Capacity at your rate
- €3,564
- More MDR role notes a quarter
- 1.5
- Return on Pro
- 11×
- Research
- Drafting
- Your review
A scenario you set, not a promise. The hours that come back go to another client, or deeper into this one.
Want these numbers on your team’s real workload?
Book a demoSources azta searches here
- EUR-Lex · Curia
- wetten.overheid.nl
- Gesetze im Internet
What stays with you
- The product facts and the supply chain, which come from your quality team.
- MDCG and competent-authority guidance, which azta does not hold.
- The quality-system decisions and who signs them.
Frequently asked questions
- Does azta hold the MDCG guidance?
- No. It holds the Regulation, other EU law and national legislation. MDCG guidance needs checking separately, and the note can mark where it applies.
- Does it cover EUDAMED registration?
- It cites the registration duties in the Regulation. Which EUDAMED modules are mandatory at a given date is something to confirm against the Commission’s current information.
- Can several colleagues work on the note?
- On Enterprise, shared workspaces keep the documents, research and drafts for a project together, with access by membership.
