EU MDR for importers: a 2026 compliance checklist for distributors

If you are an importer of dental or surgical instruments into the EEA, the UK, or Switzerland — yes, including dental clinic chains buying directly from a non-EU manufacturer — Article 13 of the EU Medical Devices Regulation (MDR) 2017/745 assigns you obligations that did not exist under the old Medical Devices Directive. Many distributors discover this during a Notified Body inspection of one of their customers, not before. This is the checklist that gets ahead of that conversation.

Who counts as an “importer” under MDR

If you are established in the European Union and you place on the Union market a device manufactured outside the Union, you are an importer (Article 2(33) MDR). This applies whether the manufacturer has an EU Authorised Representative or not, whether the device is generic Class I or specialty Class IIa, and whether you re-sell branded or under your own private label.

The misread we see most often: distributors assume that having an EU Authorised Representative on file means importer obligations transfer to them. They do not. The Authorised Representative represents the manufacturer; the importer is still you.

Article 13 — what you must verify before placing on market

Article 13(2) MDR makes the importer responsible for verifying these eight items before any device shipment reaches the EU market:

• The manufacturer has been identified and has designated an EU Authorised Representative.
• The device has been correctly classified and the conformity assessment procedure has been carried out.
• The device bears the CE marking and the EU Declaration of Conformity has been drawn up.
• The device is labelled in accordance with MDR Annex I + Annex VI requirements.
• Where applicable, a Basic UDI-DI has been assigned, and the UDI carrier appears on the device or its packaging.
• The manufacturer has registered the device in EUDAMED (or in the national equivalent during EUDAMED transition).
• For implantable devices and Class III, an implant card and patient information have been supplied.
• For Class IIa+, an annual safety and clinical performance summary is available.

If any of these eight is not in place, the device cannot lawfully be placed on the EU market. You — the importer — are legally responsible for catching the gap.

Your own EUDAMED registration

Importers must register as an economic operator in EUDAMED and obtain a Single Registration Number (SRN). Once EUDAMED’s economic-operator module is fully operational, the manufacturer’s registration of the device will require your SRN to be linked. Without it the manufacturer cannot complete the device registration.

This is the place where most importer-onboarding goes off-schedule: the SRN application can take 60-90 days, and most distributors only start it when the manufacturer requests it — after the first PO has been signed.

Record-keeping — Article 13(8)

You must keep, for the duration the device is on the market plus 10 years (15 years for implantables): the EU Declaration of Conformity, every shipping document, every quality non-conformity record, every customer complaint and your response. Article 13(8) requires this be made available to the competent authority on request. Spreadsheets work; a real document management system works better.

Vigilance and post-market — your share of the burden

Under MDR Article 87 (Reporting of serious incidents) the importer has a 15-day reporting clock from when a serious incident comes to their attention — even if the manufacturer is separately reporting through their Authorised Representative. Your customers (hospitals, dental groups, clinics) will tell you about incidents before they tell the manufacturer. Plan for it.

What we supply, what you supply

For AJ Brothers buyers in the EEA, this is the split of obligations we have in place:

What AJ Brothers supplies

• EU Declaration of Conformity (per device family, signed within the previous 12 months)
• CE technical file summary (full file under NDA on request)
• Basic UDI-DI per device family, UDI-DI per packaging level
• EU Authorised Representative letter of designation
• Labelling templates that satisfy Annex I + Annex VI
• Annual update of the safety and clinical performance summary (where required)
• Surveillance audit reports (current cycle, under NDA)

What you, the importer, must hold or arrange

• Your own SRN in EUDAMED — registered as an importer
• Confirmation that each shipment matches the labelling specification you verified
• A documented vigilance procedure with the 15-day clock and an internal owner named
• Record-keeping infrastructure for 10-year (15-year for implantables) retention
• A clearly-named regulatory point of contact, both for the competent authority and for your hospital customers

If you are an existing distributor reviewing this for the first time

You are not alone. The MDR transition extended past most distributors’ compliance bandwidth. The thing to do is: (1) inventory which of your suppliers’ devices fall under MDR; (2) for each, confirm the eight Article 13(2) items; (3) get your SRN if you don’t have one; (4) draft a vigilance procedure and name an owner. Email our QC team for a one-hour walk-through of how the AJ Brothers documentation chain maps onto each obligation in your importer checklist.

Working out distributor terms? Apply to distribute — Tier 2+ partners receive a Data Processing Addendum and the full regulatory documentation pack within one business day of NDA signature.