Attention all manufacturers. Are you aware that if an Economic Operator (EO) considers your medical device to not be in conformity with MDR requirements, they are obligated to inform the competent authorities, thus impeding progress of your supply chain channels?

The European medical device regulation places more direct responsibility on individual entities in the medical device supply chain. Who are they? Who is responsible for informing these businesses of their responsibilities according to the MDR? How are they to manage their new roles?

Something I continue to find amazing is during this 3 (now 4) year transition period, many legal manufacturers, who have principal visibility of the MDR, have not yet engaged with their economic operators to review and update contractual agreements for data sharing.

If you are a business located within the EU and place a medical device from a third country on the market in the EU, your business, large or small, is defined as an Economic Operator: Importer as per the MDR with prescribed legal obligations. Two such obligations are keeping a register of complaints and the ability to provide the competent authorities with documentation demonstrating compliance.

As an importer managing 1000’s of different devices, received from multiple manufacturers, you must be equipped with the right tools to satisfy these additional data requirements for each and every medical device that pass through your doors. 

Other additional Economic Operators (EOs) described within MDR having legal obligations are the manufacturers themselves, authorised representatives, distributors, end sterilisers and re-packagers.

It is absolutely critical for all parties to establish and confirm the management of the mandatory data exchange requirements to support each entity’s legal obligations. And given that manufactures have the largest stake in maintaining compliance, it behoves you to lead the dialogue with their affiliates. Whether the EO roles are internal or external, well established processes supported by the right technology are necessary for assuring correct and accurate data is available for each designation. Your confidential data must be managed within a secured network with all roles and permissions clearly identified.

I strongly suggest

  • European importers, distributors, re-packagers, re-labellers, replacement part retailers, authorised representatives, procedure pack assemblers and steriliser firms immediately engage with their medical device manufacturers to understand how they will manage data exchange
  • medical device manufacturers provide support for their EOs, as many remain unfamiliar with the regulations, in order to safeguard and maintain a continuous supply chain

Please refer the specific articles of the Medical Device Regulations if you are unsure whether your business meets the criteria for an Economic Operator: https://eur-lex.europa.eu/MDR (EU) 2017/745.

I’d love to hear your thoughts.  Email me at kimyoung@instem.com.

K Young