Decree covers following areas:
SECTION 1 – Subject-matter
SECTION 2 – Particulars of serious adverse incident reporting prior to the placement of a medical device on the market
SECTION 3 – Performance of distribution and import activities
SECTION 4 – Premises and technical equipment
SECTION 5 – Controls and corrective actions
SECTION 6 – List of groups of medical devices which may jeopardise the life or health of humans
SECTION 7 – Particulars of an order
SECTION 8 – Particulars of a medical device order issued in another Member State of the European Union
SECTION 9 – List of medical devices the use and handling of which is generally known
SECTION 10 – Particulars of documentation of medical devices in use
SECTION 11 – Suspected adverse incident reporting and adverse incident reporting
SECTION 12 – Scope of information on adverse incident investigation
SECTION 13 – Field safety corrective actions and safety alerts
SECTION 14 – Generic groups of medical devices
SECTION 15 – Effect