The new MDR and IVDR, consequences for importers and distributors

Requirements for importers

Are you importing devices from outside the European Union onto the European market? Then the new MDR regulations also apply to you. For instance, you must register with EUDAMED in time. Read what else you need to take into account.

Register with EUDAMED

EUDAMED is the European database in which information about medical devices and manufacturers is stored. You must register all medical devices at EUDAMED in time and keep the information up-to-date.

Check the UDI and CE marking

Medical devices have to be fitted with a special barcode, a Unique Device Identification (UDI). You have to check that this UDI has been assigned to the products you import or distribute. Also, check if your products carry CE marking, to ensure they comply with the European regulations.

Verify the manufacturer

You need to check whether the manufacturer of the medical device is known. If so, check whether the manufacturer has designated an authorised representative. You can do so by using EUDAMED.

Check the labelling and the user manual

The device must contain correct labelling and come with a user manual.

Put your details on or with the medical device

Put your name, registered trade name or registered trademark, registered office and your address on the device, its packaging or in a document.

Check the registration of your device in EUDAMED

Check if your device is registered in EUDAMED.

Please note: importers, manufacturers and authorised representatives are jointly and severally liable. Agreements must be defined in a mandate by the three parties.

Register complaints

Keep a register with complaints, returned devices, withdrawn devices and devices which did not meet the requirements. More information about the role of importers can be found in article 13 of the MDR.

Requirements for distributors

Do you have a medical supply or wholesale store or do you sell medical devices in a drugstore or supermarket? Then you are subject to stricter requirements and must comply with the following:

Check the UDI and CE marking

Medical devices have to be fitted with a special barcode, a Unique Device Identification (UDI). You have to check that this UDI has been assigned to the products you distribute. Also check if your products carry CE marking, to ensure they comply with the European regulations.

Provide a user manual

You must provide a user manual with your products.

Check the importer

Check if the importer from whom you buy your products complies with the regulations.

Inform manufacturers of complaints or reports

If you receive complaints or reports from users or healthcare providers about suspected incidents, you have to inform the manufacturer or its authorised representative and the importer straight away.

Register complaints

Keep a register with complaints, returned devices, withdrawn devices and devices which did not meet the requirements.

You are not expected to check each product separately. Instead, you are allowed to conduct spot checks (this is called a representative research method).

More information about the role of distributors can be found in article 14 of the MDR and IVDR.