On behalf of the University of Birmingham we would like to invite you to take part in a survey to identify current challenges in regulatory science in healthcare. The aim of the survey is to identify strategic areas for the development of regulatory standards, establish current and future training needs and identify the infrastructure required to support this.
The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.
The regulatory landscape for medical devices is presently very challenging. Industry is well aware that the three year transition period from a directive to a regulation ends on the 15th of May 2020, whereupon the new regulatory framework (MDR) will apply in full. This will be followed in May 2022 with the new IVD regulations.