MDR Ready? - What importers and retailers need to consider now
Regulation (EU) 2017/745 (Medical Device Regulation, MDR) has been in force since May 26, 2021 and presents not only manufacturers of medical devices, but also importers and distributors with new, binding requirements. Anyone who imports products into the European market or makes them available there must be fully aware of their role in the regulatory context - and fulfill the corresponding obligations.
In this article, we highlight the most important requirements for importers and distributors under MDR - and show you how you can best prepare now.
Role clarity as the basis for compliance
According to Article 2 MDR:
Importer: Any natural or legal person established in the EU who places a product from a third country on the market.
Distributor: Any natural or legal person who makes a product that has already been placed on the market available on the market until it is put into service.
Important: A company can be a manufacturer, importer and/or distributor at the same time - depending on the product and process. It is therefore crucial to correctly identify the respective role for each product.
Obligations for importers
Mandatory registration in EUDAMED
Importers must register separately in the European database EUDAMED, regardless of their role as a manufacturer. From January 2026, this registration will be mandatory, even for so-called legacy products.
Testing obligations before placing on the market
Before a product is placed on the market in the EU, the importer must ensure that:
A CE marking is present
An EU Declaration of Conformity is available
Instructions for use enclosed
The manufacturer is correctly named (incl. authorized representative, if applicable)
The UDI label (if required) is correctly affixed
The product is registered in EUDAMED, if applicable (from 2026)
Labeling and storage obligations
Importers must be named and addressed on the product or packaging. Copies of relevant conformity documents must be retained.
Information and cooperation obligations
In the event of suspected non-compliance, counterfeiting or serious risks, importers must:
Inform the manufacturer and, if applicable, the authorized representative
Inform the competent authority
Provide the product or enable access if required
Keep a register of complaints and recalls
Obligations for retailers
Random checks
Retailers must ensure that:
Products are CE-marked
A valid EU Declaration of Conformity is available
Instructions for use are available
information from the importer is available (for third country products)
Cooperation and communication
Dealers must be notified in the event of suspected non-compliance or risks:
Inform the manufacturer, the authorized representative and the importer, if applicable
Working with authorities and the manufacturer
Keeping a complaints register
Provide products or information at the request of the authority
Caution when making changes to the product
Importers and distributors can become manufacturers within the meaning of the MDR by making certain changes to the product - with all the associated regulatory obligations. This applies, for example, to:
Distribution under own name or brand
Change of purpose
Technical changes affecting conformity
However, translating the instructions for use or repackaging are permitted, provided that the integrity of the product is maintained. Prerequisite: A quality management system (QMS) that regulates and documents these changes - including information to the manufacturer and the responsible authority.
Don't forget legacy products
Many obligations - such as the cooperation obligations, complaint management or reporting obligations - also apply to so-called legacy products, i.e. products with old certificates under MDD/AIMDD/IVDD. The MDR Regulation and guidance documents (e.g. MDCG 2021-25) confirm this applicability.
Conclusion: MDR readiness is not a "nice to have"
Importers and distributors are under the same regulatory pressure as manufacturers - at least since the MDR became mandatory. A clear definition of roles, complete documentation, early system adaptation and practiced processes are crucial in order to be able to act in a legally compliant manner.
MEDAGENT supports you with
Whether you are an importer, retailer or manufacturer - MEDAGENT supports you with customized solutions:
Role definition and GAP analysis of your processes
Development and implementation of a compliant QMS
Advice on EUDAMED registration
Support with translation, repackaging and AR communication
Conducting mock audits for MDR readiness
Contact us for a non-binding initial consultation. We make you MDR-ready
