As of 26 May 2021, the European Union will implement stricter rules on Medical Devices (MDR). From 26 May 2022, the new regulations will also apply to In Vitro Diagnostic Regulations (IVDR). Find out what the consequences are for you as a distributor or importer.
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Date of application postponed
The European Commission has decided to postpone the date of application for the MDR by one year, to May 2021. This enables all stakeholders to focus on battling the coronavirus pandemic, and ensures the continued availability of essential medical devices. The application date for the IVDR remains the same: May 2022.
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 at EUDAMED in time. Read what else you need to take into account.
Register at 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. EUDAMED has not been released yet. It is expected to come into service in May 2022. Until then, the exisiting notification system Notis will remain in place.
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
Please check if 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.
Keep a register with complaints, returned devices, withdrawn devices and devices which did not meet the requirements.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.
Keep a register with complaints, returned devices, withdrawn devices and devices which did not meet the requirements.