Regulation (EU) 2017/745 – also known as MDR (Medical Devices Regulation) has been adopted on the 5th April 2017 and will replace the MDD (Medical Devices Regulation) and AIMDD (Active Implantable Medical Devices Directive). There is a transition period of 3 years making the regulation fully applicable in May 2020. There are massive changes compared to the MDD confronting manufacturers with numerous challenges.
For instance, there are amended and new classification rules. Some producers might find their products grouped in higher risk classes under the MDR. There will be an extended version of the Essential Requirements, now called the General Safety and Performance Principles or Requirements (GSPR). Also, the provisions for clinical performance and PMS (Post Market Surveillance) have been revised. The corresponding documents will be subject to enhanced scrutiny.
Further details can be found here.
As the transition period continues and guidance documents will be published, mdi Europa will remain at your side and guide you through.