What are the general technical requirements to bring my medical device product to the European market?
Council Directive 90/385/EEC
(5 September 2007)
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
Design and Manufacturing
6. The solutions adopted by the manufacturer for the design and construction of the devices must comply with safety principles taking account of the generally acknowledged state of the art.
7. Implantable devices must be designed, manufactured and packed in a non-reusable pack according to appropriate procedures to ensure they are sterile when placed on the market and, in the storage and transport conditions stipulated by the manufacturer, remain so until the packaging is removed and they are implanted.
8. Devices must be designed and manufactured in such a way as to remove or minimize as far as possible:
- the risk of physical injury in connection with their physical, including dimensional, features,
- risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
- risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure and acceleration,
- risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment,
- risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure,
- risks which may arise where maintenance and calibration are impossible, including:
- excessive increase of leakage currents,
- ageing of the materials used,
- excess heat generated by the device,
- decreased accuracy of any measuring or control mechanism.
9. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in I. ‘General requirements’, with particular attention being paid to:
- the choice of materials used, particularly as regards toxicity aspects,
- mutual compatibility between the materials used and biological tissues, cells and body fluids, account being taken of the anticipated use of the device,
- compatibility of the devices with the substances they are intended to administer,
- the quality of the connections, particularly in respect of safety,
- the reliability of the source of energy,
- if appropriate, that they are leakproof,
- proper functioning of the programming and control systems, including software.
For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.