011807-EN--B (2022-12_S617 S717F S900 S950 C50_IFU)
48 / 49
11 REGULATORY INFORMATION
11.1 APPLICABLE STANDARDS AND REGULATIONS
The medical devices comply with the requirement on medical devices.
They were designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system.
The information in these Instructions for Use is based on the requirements of standards to which the manufacturers of medical
devices must adhere, as stated in standard IEC 62366-1.
11.2 MEDICAL DEVICE CLASSIFICATION
The devices concerned by these Instructions for Use and manufactured by SOPRO are class I medical devices in accordance
with the European regulation on medical devices.
11.3 VIGILANCE
Any serious incident concerning the medical device or its accessories, except for the expected secondary effects must be
reported to the relevant competent authorities and to the manufacturer as soon as possible. Generally, the notification period
should consider the seriousness of the incident.
Consult local applicable regulations.
Manufacturer’s contact details: please see the last page of the Instructions for Use.
11.4 MANUFACTURER’S RESPONSIBILITY
Failure to comply with the recommendations provided by the manufacturer in this document and those supplied subsequently
in written, electronic, or whatever other form will render the warranty null and void. The manufacturer shall be released from
any liability, including for direct or indirect injuries to persons or damage to property and the environment.
Furthermore, the managers of the facility, customers or collaborators shall be held liable for any damage and/or accidents
and/or deterioration of patients’ or operators’ health or of the surrounding environment.
To Next Page
Loading...
