Decree No 62/2015 Coll.

Decree No 62/2015 Coll. implementing certain provisions of the Act on Medical Devices came into effect on the Third of April, 2015.  

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