"Qualified Person" (QP) and "European Authorised Representative" (AR) according to MDR with BEO Berlin®
"The monitoring and control of the products, their post-market surveillance and their vigilance activities ..." shall be carried out by a "...person responsible for compliance" ...as per the wording of the MDR.
In the past, BEO Berlin® has helped many manufacturers by offering the service of the "Safety Officer for Medical Devices" after MPG (German Medical Device Law), a role with similar tasks. Since our employees have the legally required qualifications according to both MPG and MDR, we will continue to offer this service. With our support you are able to continue operating within the law if you do not have a suitable person among your permanent staff. Do not hesitate to contact us for more information.
The same holds true for the European Authorised Representative (AR), a service which we have been offering our customers outside the EU and our EU customers with non-European suppliers, who act as manufacturers for a long time. We have decided to continue providing this service, despite the increased responsibility for the AR according to the MDR. The preparation involved in the MDR transition is considerable, as we would like to make it seamless. We are currently in the process of tackling the implementation with our customers and those who have already voiced an interest. Should you see the need now, because your current AR is no longer available or if the demand for the first time, we would like to ask you to contact us as soon as possible in order to coordinate details.
December 13th, 2019