Do MedTech dealers have to have a certified quality management system according to ISO 13485?

5 reasons you should consider

In the past, it was primarily the responsibility of manufacturers to ensure the conformity of their products through systematic inspections. Under the MDR, the legislature extends the obligation to other economic actors along the logistics chain, so retailers must now also check the conformity of the products they provide and identify deviations.

1. Your customers will be happy. With a certified quality management system, you show your customers that you have implemented measures that guarantee the quality of your processes at all times and that you are making your contribution to the supply chain to increase the well-being and safety of patients.

2. Secure your market position. Both manufacturers and customers can require their dealers to have a certified quality management system. Many, especially outside the EU, are already doing this.

3. Support your manufacturers in their duty to better control their sales channels, because under the MDR you as a dealer are an economic actor. This means you fall under post-market surveillance. The manufacturer also has to monitor your activities. He does this by entering into a quality assurance agreement with you that has far-reaching effects on your work.

4.Your compliance. As an economic operator, you have defined review and reporting obligations according to the MDR, which you must actively comply with. You must regularly check your products yourself for conformity; this requires that you are able to recognize non-conforming products. In addition, you must ensure the traceability of the products.

5. Manage your risks and know your obligations. Whenever you repackage products and provide and translate legally required information, you must have a quality management system in place that regulates these activities. According to the MDR, a certificate from a notified body must be presented to the responsible authority within 28 days.

Conclusion

The MDR has substantially increased the requirements for retailers. Does this result in an obligation for certification according to ISO 13485? At the moment the answer to the question must be clearly no. Nevertheless, there is a lot to be said for it. In addition to the MDR, national regulations also regulate other measures and obligations that speak for a certified quality management system according to ISO 13485.

In the course of this article, we exchanged ideas with KRÖNER MEDIZINTECHNIK GmbH, an internationally active dealer and service provider who has had its quality management system certified according to ISO 13485. In particular, regular questions from hospitals and distributors partners in other EU countries - about an ISO 13485 certificate - were an important motivation for them.