Essentials of European Medical Device Regulatory Affairs

Define intended use of the device

‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling , in the instructions and/or in promotional materials;

intended use indications contraindications warnings and precautions claims and benefits

who user whom patient

expertise

population where environment environment when concomitant compatibility

Align marketing materials with technical information – Needs upfront agreement and documentation in the tech file – Needs approval process with regulatory review to prevent ‘drift’

Establish Quality Management System to support device

Usually ISO 13485 – the harmonised standard – Framework for the policies, procedures, work

instructions, records etc., that are needed to bring your device to market. – Includes regulatory requirements (vigilance, Field safety corrective actions (FSCA), risk management etc.) – Needs to be assessed and certificated – Watch out: • Ensure scope of QMS certification covers the devices you wish to CE mark • Ensure all activities are covered between yours, your suppliers and distributors certificates