The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors.
Under both regulations, an economic operator is defined as a manufacturer, an authorized representative, an importer, or a distributor. As such, fulfillment service providers (FSPs) would not fit into this definition and would not be required to comply with the requirements of economic operators. But, if FSPs perform activities that would fall within the parameters of the definition of an economic operator, they would be responsible to comply with the regulations accordingly. While somewhat confusing, simply stated, ‘if you do the work, you need to follow the rules, regardless of your label’.
Another update in the Q&A focuses on the duality of roles under the regulations. While on one hand the same legal or natural person or entity can act as both the authorized representative (AR) and the importer, a legal or natural person or entity cannot be both the importer and distributor.
A ‘procedure pack’ is defined as a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose. Similarly, a ‘system’ is defined as a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose. Although slightly different, the message is clear that these ‘groups’ of devices are to be used together. The Q&A document states that the producer of a system or procedure pack is also the importer of the separate devices that are contained within the system or procedure pack if they are placing them on the market.
Finally, and quite interestingly, while a leasing company has no place in the supply chain of medical devices as it does not carry out any activities associated with the definitions of ‘placing on the market’ or ‘making available on the market’, it was noted that they can “depending on the specific activities they carry out”, possibly be considered an importer or distributor.
For more on this topic and other MDCG documents: Guidance – MDCG endorsed documents and other guidance – European Commission
