Medical devices should always work very effectively to ensure the best diagnostics and therapeutical benefits for the patient. At the same time, patients, clinical personnel and third parties need to be protected from potential risks when using them.
Before introducing new medical devices to the market, manufacturers are required to perfom conformity assessments in accordance with the risk class of their product. Every new product must meet "basic safety and performance requirements" according to the Regulation (EU) 2017/745 (MDR).
We are a Notified Body according to the Medical Device Regulation and CB test laboratory for the scope MED. We test the following active medical devices:
Medical devices - Product Testing and Certification
SLG is a notified body (reg.-no. 0494) for active medical devices carrying out tests for safety and essential performance characteristics according to DIN EN 60601-1 and further particular standards.
General active medical devices
- Respiratory devices, devices for oxygen therapy including hyperbaric chambers, inhalation anaesthesia
- Devices for stimulation or inhibition
- Surgical devices
- Ophthalmologic devices
- Dental devices
- Rehabilitation devices and and active prostheses
- Devices for patient positioning and transport
- Medical gas supply systems and parts thereof
Devices for imaging
- Imaging devices utilising ionising radiation
- Imaging devices utilising non-ionising radiation
- Monitoring devices of non-vital physiological parameters
- Montoring devices of vital physiological parameters
Devices for radiation therapy and thermotherapy
- Devices utilising non-ionising radiation
- Devices for hyperthermia
- Devices for hypothermia
Manufacturers are required to ensure that every new medical device meets "basic requirements" according to the Medical Devices Regulation (EU) 2017/745 (MDR) before introducing the product to the market. Our experts are entitled to carry out necessary conformity assessment procedures for active medical devices.