The MDR 2017/745 also impacts medical devices distributors, whose obligations and responsabilities grow.
Distributors are now expected to verify the conformity of the products they place on European market, through the following documentary vertifications:
- The device is CE-marked,
- The manufacturer provides an EC declaration of conformity,
- The labelling and instructions for use are compliant with the requirements of MDR 2017/745,
- The UDI (Unique Device Identification) is available,
- If the device is imported, the importer is clearly identified.
The distributor now has to record how he makes sure that the storage and transport specifications of the manufacturer are fulfilled.
Furthermore, the distributor shall record and make available upon request from the Competent Authorities all adverse event associated with the use of the device: non-compliance, customer complaint, product recall or product withdrawal.
To summarise, the distributor now plays a role inbetween the manufacturer and the Competent Authorities : he shall warn the Authority when the device is suspected to be falsified or dangerous. The distributor will contribute to reinforce the post-market surveillance of medical devices.
If you are a medical device distributor, feel free to contact us should you need any details.