Essential Requirements
What are the general technical requirements for design and construction to bring my medical device product to the European market?
COUNCIL DIRECTIVE 93/42/EEC
ANNEX I
ESSENTIAL REQUIREMENTS
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
9. Construction and environmental properties
9.1. 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 or in the instructions for use.
9.2. Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible:
- the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features,
- risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure and acceleration,
- the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given,
- risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism.
9.3. Devices must be designed and manufactured in such a way as to minimize 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 flammable substances or to substances which could cause combustion.