European Union (EU) medical device regulations (EU MDR) have significantly increased the requirements for distributors. If you are currently a distributor of medical devices in the EU, or are considering doing so, it is important that you understand these new requirements to avoid serious, multi-year custodial sentences if you are not in compliance.
The MDR defines a distributor as “any natural or legal person in the delivery chain, who provides a product on the market up to the time of commissioning, with the exception of the manufacturer or importer.” A distributor engages in activities that include:
- Purchase of products from manufacturers or other (interim) distributors,
- Marketing and sale of products to end-customers or other distributors,
- Storage and transport of products,
- Possibly attaching own labels,
- Instruction of users,
- Support in installation and commissioning,
- Answering user questions, and
- Handling customer complaints and providing feedback to the manufacturer.
The MDR now requires distributors to review the products they sell so that they answer the following medical device compliance questions:
- Does the product bear a CE symbol?
- Has a declaration of conformity been issued for the product?
- Has the importer listed its name and address on the product, packaging or a document?
- Has the importer not covered the labels of the manufacturer with its own additional labels?
- Has the manufacturer issued a UDI?
- Does the product appear to conform to the legal requirements?
If one of these conditions is not fulfilled, the distributor may not sell the product and must inform the manufacturer, importer, and the EU representatives. There will be consequences to those that distribute products that do not meet these requirements. Distributors can no longer rely upon manufacturers or importers to fulfill all these requirements nor assume they have the necessary valid certificates – they must confirm this information themselves.
It’s important to note a critical issue that European legislators have yet to resolve: if a distributor discovers a falsified product in their warehouse, they are liable. BUT, they cannot send the product back and they cannot destroy it. Both actions are punishable under the law. What’s a distributor to do? The answer is not yet clear.
Additional product-related medical device compliance activities required of distributors:
- Storage and transportation pursuant to manufacturer specifications.
- Collect complaints and incident reports and forward them to manufacturers and possibly importers. This also applies to products for which the distributor itself has doubts about the conformity.
- Keep a register of non-conforming products, recalls, and withdrawals.
- Inform authorities about unsafe and falsified products as well as corrective actions and provide information and documentation upon request.
Distributors and importers are now part of the post-market surveillance and reporting system and are now required to be able to trace the products they sell to help ensure compliance. Even further, distributors must now have a quality management system in place that regulates the following actions:
- Product repackaging and checking that repackaging does not affect conformity.
- Creation/provision of information and checking that these fulfill the legal requirements.
- Translating the information.
- Receive/order information about the manufacturer’s corrective actions.
This blog post is a brief summary of the major EU MDR requirement changes. There are a number of lesser additional and ancillary requirements that may affect you as a distributor. We encourage you to work with a qualified, experienced regulatory consulting firm such as MEDIcept to ensure you fulfill all the new requirements so you can operate as efficiently and successfully as possible.
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MEDIcept is an international, vertically integrated, medical device quality, regulatory, and clinical consulting firm. Since 1996, we have worked with over 1000 companies, ranging from large corporations to pre-revenue start-ups. With decades of combined experience in all aspects of the medical device industry, we are uniquely qualified to help medical device and in-vitro diagnostic firms navigate complex FDA and international regulatory pathways, reduce business risk and time-to-market, while maximizing the potential for success.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.