PRRC: Responsible person in medical technology companies

While the MDR assigns the responsibility, it does not describe how the Responsible Person shall use this responsibility in practice.

Here, it is up to the manufacturer to decide whether there should be a superordinate responsible person who monitors all areas - such as technical documentation, post-market surveillance, vigilance, product conformity or the submission of a declaration for investigational devices - or whether a separate responsible person should be appointed for each area. Likewise, a decision must be made as to whether the Responsible Person will perform all of the tasks associated with assuming responsibility themselves, or whether the performance will be delegated and the Responsible Person will act primarily as a supervisory body. Once these decisions have been made, the new function of the responsible person(s), including the duties and tasks, must also be mapped accordingly in the quality management system.

In the case of an EU representative, the responsible person differs from that of a manufacturer. Here, the responsible person assumes responsibilities and tasks as a link between the EU and non-EU. The focus here is therefore less on the duties of the manufacturer and more on ensuring complete and correct documentation for the EU market, as well as carrying out the necessary registrations and communication with the manufacturer and the competent authorities.