With the changes of the Medical Device Law Implementation Act (MPDG) draft, we are constantly discussing the impact of expected changes and increase of requirements amongst medical colleagues, clients and authorities, especially for former so-called “scientific studies”.
This new regulation specifies “other” clinical trials under Art. 82 (1) MDR (EU) 2017/745 and adds up to clinical trials under the German Medicines Act (AMG), clinical trials under Art. 62 (1) EU Medical Devices Directive (MDR (EU) 2017/745), and clinical trials on food supplements, cosmetics or similar.
We are now awaiting the adaptation of the new law that certainly by increasing needed qualifications and regulatory standards will make clinical studies more elaborate and expensive while increasing the safety and validity of data. We will keep you informed!