Conducted by FDA to monitor device performance, Medical Device Reporting ( MDR ) is one of the most powerful controlling tools to detect possible device-related issues and support the assessments of these products. In Europe, this new set of regulation has contributed into the retailing of Medical Devices in their marketplace including: Directive 93/42/EEC (for Medical Devices) and Directive 90/385/EEC for Active Implantable Medical Devices.
What are some significant changes in this New regulation - Medical Device Reporting
Comparing the previous applied regulation MDR has some of the extension in service which can provide further support and precisely ensure the quality of Medical Products that put into marketplace in Europe
- Extended area of application (include non Medical Devices)
- UDI: Unique product number for every medical device
- More stringent requirements for technical document (TD)
- More stringent requirements for responsible persons: Expert knowledge of Medical Devices
- New scrutiny procedure for high risk medical devices
- More stringent requirements for clinical assessments and testing: Data collection for even after market launch.
- Notified bodies more strictly regulated: New body to be chosen and inspected
- EUDAMED: Europe-wide database for more transparency and cooperation.
What is the Transitional Provisions for MDR:
In the case that the manufacturer has already been authorized it will be valid for that moment. However, the paper should be noticed by notified bodies on or after May 25, 2017 to put into practice and prolong until Nov 25, 2017 to complete any legal acts relating to areas of competence for nomination of the nominated body.
Within the 4 years transition period the certification is possible for the new in-line with the old or new registration. The device is applicable for application on May 26, 2021 with no scope extension and substantial changes of MDD and AIMDD of the service. Furthermore they become void on May 27, 2024.