Our products are MDR certified
What is an MDR certificate and why is it important?
An MDR certificate stands for compliance with the Medical Device Regulation (MDR), an important European regulation that ensures the safety, quality, and effectiveness of medical devices. In the Netherlands, this regulation has been translated into the Medical Devices Act, which has introduced significant changes, especially for class 2 and class 3 devices. The MDR has replaced existing European directives and creates a uniform, stricter approach for the development, sale, use, and monitoring of medical devices across the EU. Manufacturers now have more obligations, including:
- Mandatory monitoring and registration of incidents to minimize safety risks.
- Collection of user experiences to assess the performance of devices in practice.
- Analysis of usage trends to identify possible improvements or risks early on..
Importance of the MDR certificate
Obtaining an MDR certificate is a crucial step for manufacturers and distributors to comply with the new regulation. Without this certificate, medical devices cannot be marketed or used within the EU.
The tightened requirements under the MDR ensure that the safety and reliability of devices are maintained throughout their lifecycle. This is especially important for devices in higher risk classes (class 2 and 3), as these directly affect the health and well-being of patients.
In short, the MDR certificate is not just an obligation, but also a guarantee of quality and safety in healthcare.
Obligations for manufacturers
The MDR imposes significant obligations on manufacturers of medical devices. These include, among others.
- Monitoring and registering incidents to identify risks early.
- Collecting user experiences to evaluate the performance of devices in practice.
- Tracking trends in the use of devices to identify improvement points and safety risks.
One of the most impactful changes is the mandatory registration of each device in EUDAMED, the European database for medical devices. Starting from May 20, 2021, all new products marketed must be registered in this database and provided with a Unique Device Identifier (UDI). This UDI code is essential for traceability and identification of devices.
Specific obligations for class 1 devices
Common devices in class 1 include scissors, nurse scissors sets, tourniquets, and stethoscopes. For class 1 devices, the following obligations apply:
- New products launched after May 20, 2021, must have a registered UDI code in EUDAMED.
- Older products produced before May 26, 2021, do not need a UDI code but can only be used if properly maintained and deemed safe.
It is important to use products in healthcare that are MDR certified. Medical devices such as stethoscopes, tourniquets, and nurse scissor sets with an MDR certificate meet the required standards. This ensures that the device complies with all necessary requirements.
For detailed information on the MDR and medical devices, it is advisable to visit the government website. Here you will find extensive information on the legislation and guidelines that apply. This source provides in-depth insight into the MDR requirements and helps better understand this complex regulation. It is crucial for all stakeholders in the medical sector to stay well-informed and comply with the MDR to ensure the highest standards of safety and quality.