All POWERbreathe Models are Class 1 Medical Devices
Medical Devices Directive
The main purpose of the Directive is to harmonise national controls, so allowing free movement of medical devices throughout the European Union and EFTA whilst at the same time ensuring that all devices within the Union are reasonably safe in use.
The Directive covers most medical devices other than active implantable medical devices and in vitro diagnostics.
- Specifies “essential requirements” which must be met before any device can be placed on the market
- Introduces controls covering the safety, performance, specification, design, manufacture and packaging of devices
- Specifies requirements for assessment of clinical investigation protocols, and the evaluation of any adverse incidents that occur
- Introduces a system of assessment of clinical investigation protocols, which is matched to the degree of risk inherent in the device
- Empowers a Competent Authority to identify and designate “notified bodies” who check and verify that devices meet the relevant essential requirements
EC Medical Devices Directives Guidance Notes for Manufacturers of Class 1 Medical Devices
ISO Certificates of approval for ‘Design & manufacture of medical devices for improvement of respiratory function'