CE marking is where European market entry starts, not where it ends
What a medical device company should settle with its regulatory team before it chooses markets and distributors.
A CE mark lets a medical device be sold anywhere in the European Union. In practice, many companies that get one still do not know where to sell first, how hospitals will pay for the device, or who will sell it. The regulatory work and the commercial work are often done by different people at different times. Several decisions taken during CE marking later decide what the sales team can do, so the two should be planned together.
The intended purpose sets the limits of what you can sell
Under the Medical Device Regulation (MDR), the intended purpose a manufacturer states in its technical documentation decides the device's risk class, the clinical evidence it needs and the claims it may make. A distributor's sales representative may only promote the device within that purpose. If the intended purpose is written narrowly to make certification easier, the device may later be too limited for the patient groups or settings in which a hospital would buy it. If it is written too broadly, it may need clinical evidence the company cannot afford.
The same evidence is later used to argue for reimbursement and to answer tender questions. It is worth asking early which clinical data a payer or a hospital procurement team will want to see, and whether the clinical evaluation plan can produce it at the same time.
A non-EU manufacturer needs more than a certificate
A manufacturer based outside the EU must appoint an authorised representative in the EU, who is named on the label and shares responsibility for compliance. Every manufacturer also needs a person responsible for regulatory compliance; small companies can use an external one.
Distributors and importers have their own obligations under Article 13 and Article 14 of the MDR. Before they sell a device, they must check that it carries the CE mark, that a declaration of conformity exists, and that the labels and instructions for use are in the language required by each country. A good distributor will ask for this documentation in the first meeting. A manufacturer that cannot provide it looks unprepared, and the distributor will move on to the next product.
Each country adds its own requirements
The CE mark is European, but language rules for labels and instructions, national registration of devices and the rules for advertising to healthcare professionals are set nationally. In the Nordic and Baltic countries, hospitals buy mostly through public tenders, which usually ask for the CE certificate, the declaration of conformity and documentation in the local language as part of the bid. These are small tasks, but if they are left until a tender is open, the company can miss it.
The rules are changing
Most devices certified under the old directives can stay on the market until the end of 2027 or 2028, depending on their class, provided the manufacturer moves to MDR certification in time. In December 2025 the European Commission proposed a targeted revision of the MDR. Among other changes, it would remove the five-year limit on certificate validity, move some devices and much medical software into lower risk classes, reduce notified body fees for micro and small companies, and introduce priority review for breakthrough and orphan devices. The proposal is still going through the European Parliament and the Council, and adoption is expected in 2027. Until then, the current MDR applies in full, and a market entry plan should not count on changes that have not been adopted.
When to bring in a regulatory specialist
At HealthChain we work on market selection, channels and distributors. Regulatory affairs is specialist work, and when a project needs it we bring in experienced regulatory consultants from our network. In our experience, involving them early costs less than fixing problems later. The questions we ask together are practical. Does the intended purpose cover the patients and settings we plan to sell to? Is the clinical evidence enough for payers and tenders as well as for the notified body? Is the documentation ready for a distributor's first due diligence? Which national requirements apply in the first target countries?
If your device is CE-marked or close to it and you are planning which European markets to enter, book a 30-minute call.
