What are the general technical requirements to bring my medical device product to the European market?
(18 June 2009)
B. DESIGN AND MANUFACTURING REQUIREMENTS
3. Manufacturing and environmental properties
3.1. If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system, must be safe and must not impair the specified performances of the devices. Any restrictions on use must be indicated on the label and/or in the instructions for use.
3.2. Devices must be designed and manufactured in such a way as to reduce as far as possible the risks linked to their use in conjunction with materials, substances and gases with which they may come into contact during normal conditions of use.
3.3. Devices must be designed and manufactured in such a way as to remove or reduce as far as possible:
- the risk of injury linked to their physical features (in particular aspects of volume × pressure, dimension and, where appropriate, ergonomic features),
- risks linked to reasonably foreseeable external influences, such as magnetic fields, external electrical effects, electrostatic discharge, pressure, humidity, temperature or variations in pressure or acceleration or accidental penetration of substances into the device.
Devices must be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity of electromagnetic disturbance to enable them to operate as intended.
3.4. Devices must be designed and manufactured in such a way as to reduce as far as possible the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to or use in association with flammable substances or substances which could cause combustion.
3.5. Devices must be designed and manufactured in such a way as to facilitate the management of safe waste disposal.
3.6. The measuring, monitoring or display scale (including colour change and other visual indicators) must be designed and manufactured in line with ergonomic principles, taking account of the intended purpose of the device.