On 18 August 2021, the Medical Device Coordination Group (MDCG), composed of representatives of all Member States and chaired by a representative of the European Commission, published the guidance on procedures for the translation of labels and instructions for use, as well as the repackaging of medical devices. The guidance is intended to provide assistance to distributors and importers carrying out the above activities by clarifying the relevant requirements, pursuant to Article 16 of the Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices respectively.
In particular, the guidance clarifies that importers and distributors must have a Quality Management System (QMS) able to ensure the accuracy of the relevant procedures and that said QMS must include, among others, the management of corrective actions, including procedures for handling non-conforming devices and market recalls due to translation and/or repackaging activities, including, when necessary, field safety corrective actions and verification of their effectiveness, procedures to ensure traceability of the devices, as well as labels, instructions for use and outer packaging indicating the changes made to the product.
Moreover, importers and distributors must obtain a certificate issued by a notified body attesting the compliance of the QMS with the requirements provided for by the same provision. In this regard, the guidance describes the phases and specific aspects that must characterize the relevant certification process and the contents of the certificate, also providing indications on the management of the certificate itself, including the duration of its validity and the need to perform on-site audits.