EU: MDCG guidance on Article 16(4) MDR

The MDCG has published a guidance document in which it sets out the specifications for distributors, importers and notified bodies in accordance with Article 16(4) in more detail. This describes the prerequisites for a situation in which distributors or importers repackage medical devices or translate associated information without becoming manufacturers themselves.

The guidance explains the minimum requirements for the required quality management system, the certification scheme that must be established, the content of certificates, and supervision including auditing by the notified body. This provides an important basis for actors and notified bodies, which will enable them to fulfil the requirements of the MDR in this respect.