Regulatory Open Forum

Hi

In cases where the virtual manufacturer (i.e has their own trademark) becomes the distributor and the legal manufacturer is separately mentioned on the label; how does the MDR obligations under the articles 25 and 31 be fulfilled, as the virtual manufacturer has the agreement with their importers where the legal manufacturer is not involved.

Thanks & Regards,

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Hi Erik,

Thanks for your feedback I am referring to the below exception , underlined

"EU MDR

Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons 1.A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following: (a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;"

"Article 16 in the UK guidance on virtual manufacturing

If a virtual manufacturer wants to change from being the legal manufacturer to the distributor

A virtual manufacturer will be considered a distributor and not the manufacturer in the following situations where they:

            a. provide a translation of the information supplied by the manufacturer for the purpose of making the product available in a different EU member state (without affecting the integrity and detail of the information provided by the manufacturer). The manufacturer must have a process to verify that all translations are fit for purpose prior to authorisation

            b. change the size and/or presentation of the outer packaging of a device that has already been placed on the market without affecting the integrity of the device itself

            c. affix their brand name or trademark on the labelling with the agreement of the manufacturer and the manufacturer is identified on the labelling and packaging

            d. stipulate clearly who the device is 'distributed by' and 'manufactured by' on the packaging and labelling

            e. do not change the intended purpose of the device or modify the device or its packaging in such a way that its compliance with the legislation is affected.

In order to be considered as the distributor there would need to be signed agreement with the manufacturer. The manufacturer's name must be visible as the legal manufacturer on the packaging and labelling. These details should be easy to read. There is the option for the distributor to be identified on the packaging and labelling with the term 'distributed by'.