The Medical Device Directives will soon be replaced by the Medical Device Regulation -
Both regulations are in the final stages of the legislative procedure and are expected to be finalized sometime in 2016, allowing them to come into effect by the end of 2016, or early 2017.
The proposed MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the proposed regulation include:
• Product scope expansion -
• More stringent clinical evidence -
• Identification of “qualified person” -
• Implementation of unique device identification -
• Rigorous post-
• Specifications -
In conclusion, the MDR will bring about very significant changes that will affect all devices from manufacturers currently on the European market. Not only will the administrative burden increase substantially as a result of registration requirements and UDI, but manufacturers will also have to revisit all technical files and the quality system for all their devices currently on the market. They may need to generate additional clinical evidence for devices currently on the market in order to be able to transition them to the new regime implemented by the MDR.
Consequently, manufacturers must take a pro-
For the new devices manufacturers must decide whether they want to comply with the new rules already during the transitional period or when that period expires. Again, a pro-