What is MDR?
"MDR" stands for Medical Device Regulation. It is a regulatory framework implemented by the European Union (EU) to ensure the safety, quality and effectiveness of medical devices placed on the market within the EU. The MDR was officially adopted by the EU in April 2017 and the transition period for implementation was scheduled to be completed by the 26th of May 26, 2021. However, due to delays, the transition period has been extended to the 31st of December 2028. The MDR is mandatory for medical device manufacturers selling products within the EU.
The MDR will gradually replace the previous Medical Device Directive (MDD) and introduce stricter requirements for manufacturers, importers, and distributors of medical devices within EU.
The main objective of the MDR is to improve patient safety, improve the traceability of medical devices and strengthen the monitoring of these products throughout their life cycle. The regulation applies to a wide range of medical devices, including implants, diagnostic equipment, surgical instruments, software, and other medical equipment used for treatment or diagnosis.
Some key features of MDR include:
- Increased Scrutiny: The MDR introduces more stringent requirements for clinical evaluations, post-marketing surveillance and clinical investigations. Manufacturers must provide more clinical data to support the safety and performance of their devices.
- Unique Device Identification (UDI): Each medical device must have a unique identification code, which allows for improved traceability, post-market surveillance and product recall.
- Enhanced vigilance and reporting: the MDR establishes a centralized EU database called EUDAMED, which collects and stores information on medical devices, adverse events, and other safety-related incidents. Manufacturers must report incidents to the authorities.
- Classification changes: MDR introduces new classification rules for medical devices, which may lead to the reclassification of some products. Higher risk products require the involvement of a notified body to assess compliance.
- Increased transparency: The MDR aims to increase transparency by providing patients and healthcare professionals with more accessible information about medical devices through a publicly available database.
