General Requirements?

Essential Requirements
What are the general technical requirements to bring my medical device product to the European market?

Council Directive 90/385/EEC
(5 September 2007)

1.   The devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients. They must not present any risk to the persons implanting them or, where applicable, to other persons.

2.   The devices must achieve the performances intended by the manufacturer, viz. be designed and manufactured in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a) as specified by him.

3.   The characteristics and performances referred to in sections 1 and 2 must not be adversely affected to such a degree that the clinical condition and safety of the patients or, as appropriate, of other persons are compromised during the lifetime of the device anticipated by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.

4.   The devices must be designed, manufactured and packed in such a way that their characteristics and performances are not adversely affected in the storage and transport conditions laid down by the manufacturer (temperature, humidity, etc.).

5.   Any side effects or undesirable conditions must constitute acceptable risks when weighed against the performances intended.

5a. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.