Choosing a distributor in Europe: what to check before you sign
For most small and mid-sized medical device companies, a distributor is the fastest way into a new European country. It is also the decision that is hardest to reverse. Exclusive agreements often run for several years, and ending one early can be expensive. In my experience, most distributor relationships that disappoint were set up to disappoint before the contract was signed.
Start with the market, not the distributor
The right distributor depends on where the device will be sold and how it will be bought. A company selling into public tenders needs a partner with a record of winning them and the administrative capacity to prepare bids. A company selling to private clinics needs a sales team that visits those clinics regularly. Deciding this first narrows a long list of names to a handful of real candidates.
What to check
I look at five things when assessing a distributor.
Customer access. Which hospitals and clinics does the distributor already sell to, and in which departments? A strong presence in cardiology does little for an orthopaedic product.
Portfolio fit. A device that complements the distributor's existing products gets attention. A device that competes with a larger principal's product usually does not.
Tender record. In tender-driven markets, ask which tenders the distributor has won in the last two years and for which principals.
Clinical capability. Many devices need product specialists in the operating room or on the ward. Check who those people are and how many other products they support.
Regulatory readiness. Under the EU Medical Device Regulation, distributors have their own obligations for traceability, complaint handling and vigilance. A partner who cannot explain how they meet them is a risk to your CE mark.
Agree the plan before the contract
The most useful document in a new distributor relationship is not the contract but the business plan behind it. It should state the target accounts for the first year, the tenders expected, the training and marketing support the manufacturer will provide, and the minimum volumes that keep exclusivity in place. Without agreed numbers, there is nothing to review after six months except impressions.
Manage the first year closely
The first year decides whether the relationship works. Monthly calls on pipeline and tenders, joint visits to key accounts and a formal review at six and twelve months keep both sides honest. They also give the manufacturer early warning if the product is not getting the attention it needs, while there is still time to fix it.
If you are looking for distributors in the Nordics, the Baltics or elsewhere in Europe, I am happy to talk through how to approach it. You can reach me through the contact form on this site.
