Guide for the installation and maintenance of medical devices for the diagnosis and treatment of sleepapnea syndrome outside a hospital and laying down the notification arrangements for companies

Royal Decree designating the guide applicable to the installation and maintenance of medical devicesintended for the diagnosis and treatment of sleep apnea syndrome outside a hospital and laying down thenotification arrangements [...]

The purpose of this draft is to implement Article 60, § 2, subparagraphs 1 and 3, of the Act of 15 December2013 on medical devices.

First, it makes it mandatory to comply with the “Guide for the establishment of a self-monitoring system relatedto the installation, maintenance and/or removal of medical devices as part of the diagnosis and treatment ofsleep apnea syndrome for companies that install and/or maintain the devices concerned in the home ofpatients”, by companies that install and/or maintain at home MEDDEVs specific to the treatment and diagnosisof sleep apnea.
This guide was previously approved by the AFMPS (in accordance with Article 60, § 1 and the RD of30/10/2018 on the procedure and modalities for the approval of the guides referred to in Article 60, § 1, of theAct of 15 December 2013 on medical devices).
The guide as approved is attached to the draft Order.