A reminder what it takes from MDD to MDR
The new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within companies.
The MDR has not yet gone into full effect and is currently in a transition period. For all medical devices, MDR regulations should go into effect on May 26, 2020. But due to the situation with COVID-19, the European Commission released a proposal that would postpone for a year the Medical Devices Regulation (MDR) from taking effect on the mentioned date.
While medical device companies begin planning their transition program to bring their organizations into compliance under the new Regulation, it’s important to be aware of all the major changes that will require planning and action. The clock is ticking, even though it may come to the delay.
Key changes on new MDR
Let’s remind ourselves about the changes included in the regulation:
- The definition of medical devices and active implantable medical devices covered under the MDR is expanded to include devices that have not a medical intended purpose and the devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.
- Device manufacturers are required to identify at least one person within their organization who is ultimately responsible for all aspects of compliance with the requirements of the new regulation.
- The MDR mandates the use of unique device identification (UDI). In addition, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information on approved medical devices.
- The MDR request increased post-market surveillance authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers will also be required in many cases.
- All clinical evidence must be updated for existing medical devices and must be clear, convincing, and publicly available. Additionally, clinical evaluation reports and summaries of safety and clinical performance for implantable devices and Class III devices should be updated at least once every year.
The new regulations intend to increase medical device safety and effectiveness in the EU Market while addressing weaknesses revealed in the implementation of MDD.