MHRA has now published the final version of its lomg-awaited guidance document ‘Virtual manufacturing of medical devices’.
New sections now cover the options for a virtual manufacturer when their OEM loses their CE certificate, and on changing from being the legal manufacturer to being the distributor. In the first case, the manufacturer should:
a) obtain evidence of the suspension/withdrawal of the certificate
b) consider whether there is a safety concern and any impact on the virtual manufacturer’s own certificate and products on the market
c) understand what arrangement (if any) the OEM is under with their local competent authority
d) consider using the OEM as a critical supplier to allow continued supply of the virtual manufacturer’s product
e) inform the notified body immediately of the loss of the OEM’s certificate.
Differentiation between a distributor and a virtual manufacturer depends greatly on how the device and the information provided with it is presented. As long as the intended purpose of the devices is not changed and compliance with the legislation is not affected by changes to the packaging then the company can be a distributor. Their brand name may appear on the packaging with the manufacturer’s agreement and the distributor is permitted to provide translations of information supplied by the manufacturer as long as the translation is verified.
They may 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. It is important that an agreement exists with the manufacturer and the manufacturer’s name must be visible as the legal manufacturer. Use of the term ‘distributed by’ is permitted.