The medical devices sector is undergoing changes due to the new Medical Devices Regulation (MDR). This new regulation will be mandatory starting from the 26th of May 2020 and will replace EU’s current Medical Devices Directive (93/42/EEC) and the EU’s Directive relating to active implantable medical devices (90/385/EEC).
The new MDR’s goal is to ensure patients’ safety when using medical devices that are becoming more and more complex each day. This directly affects the manufacturers of medical devices as it represents a significant change in the regulatory framework of the European Union.
What are some of the MDR key changes?
These are some of the key changes device manufacturers should be aware of:
- New classification of medical devices according to risk, contact duration and invasiveness. The MDR will require device manufacturers to review the new classification system and update their technical documentation accordingly.
- Medical device manufacturers will also be required to collect and keep post-marketing clinical data as part of the continuous assessment of potential safety risks. This will mean more rigorous clinical evidence for certain devices.
- Clinical research must be conducted in case medical device manufacturers do not have sufficient clinical evidence to support both safety and performance of their devices.
How can Siens Translation help you?
The new MDR imposes strict demands on medical device manufacturers.
In Siens Translation we are aware of all these changes and, as an expert in medical devices translations, we can help you with our team of linguists specialised into up to 23 languages.
Do you have any questions?