Trainings on EMC and product safety

MDR-Competence GbR

Düsseldorf, Germany

The transition period MDD to MDR has ended on May 26th, 2021. Now, the new Medical Devices Regulation (MDR) (EU) 2017/745 is fully enforced and replaces the previous Medical Device Directive (MDD) 93/42/EEC. In Germany, the new Medizinprodukterecht-Durchführungsgesetz (MPDG) has replaced the former Medizinproduktegesetz (MPG). The MPDG is intended as a complement to the MDR. As a help for implementation of the MDR requirements the Medical Device Coordination Group (MDCG) was established in accordance with article 103 of the MDR. Not all planned guidance documents are already available, therefore all economic operators are advised to keep an eye on the actual situation of these documents. Among many novelties introduced by the MDR, one focus is set on cybersecurity. The MDR requires the manufacturers to develop and manufacture their products in accordance with the state of the art taking into account the principles of risk management, including information security, as well as to set out minimum requirements concerning IT security measures, including protection against unauthorized access. This requirements for cybersecurity must be ensured throughout the entire life cycle of the medical device. Another focus of the MDR is the technical documentation and the technical documentation on Post Market Surveillance, which have been expanded and have now more detailed requirements.