Regulations And Standards; Applicable Standards And Regulations; Manufacturer's Responsibility - Comeg DUO Full HD Manuel D'utilisation

11 Regulations and
standards

11.1 Applicable standards and regulations

This medical device complies with the essential requirements of European Directive 93/42/EEC
and European Regulation 2017/745. It was designed and manufactured in accordance with an
EN ISO 13485-certified quality assurance system.The information in this user manual 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 class of the device
The devices concerned by this user manual and manufactured by SOPRO are Class I medical
devices according to the European Directive 93/42/EEC and European Regulation (EU)
2017/745.
11.3 Vigilance
Any serious incident concerning the medical device or its accessories, with the exception
of the expected secondary effects must be reported to the relevant competent authorities
and to the manufacturer as soon as possible. Generally speaking, the notification period
should take into account the seriousness of the incident. Consult local applicable regulations.
Manufacturer's contact details: please see the last page of the manual.

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.
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