Matachana MDR (Medical Device Regulation)
Since May 2024 MATACHANA has been MDR-CERTIFIED for its wide range of Steam and Low Temperature sterilizers.
The MDR 2017/745 (Medical Devices Regulation) is the European law that replaces the current MDD 93/42/EC (Medical Devices Directive) and introduces significant changes to current legislation. These changes have several clear purposes:
1. Improve documentation and clinical studies: The MDR requires more comprehensive and rigorous documentation for Medical Devices (MD). The importance of clinical studies to support the safety and efficacy of devices is also emphasised.
2. Post-Market Surveillance (PMS): The MDR establishes a more rigorous monitoring system once the devices are on the market. This allows the early detection of problems and a more effective response to protect patients and users.
3. Improved traceability: Both the manufacturers and authorities of member countries must guarantee solid traceability of MD. The public unique identification system (UDI code) makes this task easier.
In short, the MDR seeks to increase patient and user safety through closer monitoring of devices throughout their lifetime.
Antonio Matachana, S.A. is one of the leading companies in the sector in obtaining the MDR certification for all its sterilizers since May this year. This achievement was possible after a complex and demanding audit process carried out by the Notified Body, the TÜV Rheinland (0197), which lasted for several months.
