The authors of the MDR have taken a good look along the typical supply chain that brings a medical device from the manufacturer to the customer, a healthcare institution, medical professional or a patient. But they have not stopped at identifying these economic operators. They have also assigned obligations that each of them must fulfill to ensure that only safe and effective medical devices are brought and kept in the market.
While the currently still applicable Medical Devices Directive 93/42/EEC stresses the importance of the manufacturer, the authors of the MDR have realized the significance also of the distributor. As a result, the MDR assigns a number of obligations also to the distributors of medical devices.
These obligations include:
- Verifying the compliance of medical devices and ensuring the traceability of every device delivered to customers
- Active participation in vigilance activities, incl. reporting of suspected incidents, supporting device recalls and field safety corrective actions etc.
- Collecting, documenting and reporting of non-conforming devices, complaints and suspected incidents and feedback
- Monitoring of local legal and regulatory changes
- Participation in medical device training with learning success control (ISO 13485:2016)
- Translation of Instructions for Use, graphical user interfaces and labeling materials into the local authorized language(s)
- Cooperation with the competent authorities
- Enabling IMAGE to carry out audits to ensure the distributor’s compliance with the regulations
What are the consequences?
It was time to review our current sales partner contracts in the light of the new MDR. And we concluded that, in their current form, they do not meet the new regulatory requirements. But, we are convinced of the importance of putting our relationship with all our sales and service partners in the European Economic Area on a solid legal footing.
Therefore, we have revised and updated our sales partner agreement to include the new obligations. Throughout the months of April and May, we will contact each of EEA partners to discuss our future relationship and offer them an MDR compliant contract.
If you have not yet heard from us, feel free to contact your IMAGE sales rep at salesimage-systems[dot]biz.