January 29, 2019

BSI first UK notified body to achieve successful MDR designation

BSI was informed on January 21st, 2019 by the Medicines and Healthcare products Regulatory Agency (MHRA) that its UK notified body (0086) is the first in Europe to be designated to the new MDR (EU 2017/745).

BSI will now be able to provide conformity assessments to the full scope of the MDR. Please see the NANDO information system for further details on BSI’s scope.

BSI recently announced that it will confirm shortly when it will begin taking applications to the MDR.