After the two guidance documents related to the obligations, under article 16, of importers and distributors involved in translation or device repackaging (MDCG 2021-23 and -26), the MDCG group has tackled the responsibilities of those economic operators from a more general perspective, not limited to article 16. The result is MDCG 2021-27, guidance document in the form of questions and answers, published before Christmas.Q&A guidance documents are typically quite practical and effective in providing useful information. In this case, however, the goal is only partially achieved: there is something interesting in the document, but it is mixed with a lot of information that could be directly obtained through a careful analysis of article 13 and 14 or of the Commission’s Blue Guide.
Let’s leave the obvious out and see the main things we have learnt from this document:
- Shops, community pharmacies and other retailers (including online ones) are considered distributors (or importers in case the device is obtained directly from a non-EU company) and are therefore required to meet the requirements of article 14 (or 13 in case of importers). This does not include hospital pharmacies that provide devices for internal hospital use only. This expectation is going to be tough on big retailer chains; how our local pharmacies will be able to comply is left to be seen.
- It is confirmed (as we anticipated in a vlog several months ago) that the accompanying documentation on which the importer is identified must be a document that stays with the device up to the final user. So, it can be for example on the label, on the IFU, on an additional leaflet inserted in the primary packaging; but it cannot be on a shipping document that is left in a central warehouse.
- Distributors can conduct the checks described in article 14(2) on a sample basis, excluding the verification of importer’s name and details. Importers do not have the opportunity of sampling. This is not new however we were all hoping for some practical solution that would not require a 100% verification of all products. And for the moment we have been disappointed.
- Importers or distributors can delegate/subcontract part of the checks, but they maintain the legal responsibility of those. In contrast to this, the document seems to suggest that the operational checks cannot be delegated to the authorize representative or to another economic operator (upstream in the supply chain)
- Although not new and not surprising, it is worth mentioning that the document highlights once again how article 7 applies to importers and distributors too: so, they cannot make misleading or false claims related to the devices they handle.
Even this time the overall feeling about the guidance document is dual: there is certainly some useful information, but we were hoping for more. A lot of questions remain open, for example: is an importer always required? Also, when a manufacturer from a third country sells directly to a hospital? How will importers practically conduct 100% inspections on devices handled in very large quantities? Is an “overall” importer required for procedure packs?
If you are an importer or a distributor (or even a manufacturer) you can just hope for more clarity to be provided with additional guidance. However, there is not much in either the MDCG’s or the Commission’s pipelines, so you will be better off starting the implementation of the requirements in the worst case scenario, i.e. verbatim from the text of the regulation. And if you need support with that, please get in touch with us at info@qservegroup.com. We will be more than happy to help you navigate through this jungle.