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Council Directive 90/385/EEC of 20 June 1990
On the approximation of the laws of the Member States relating to active implantable medical devices
- Recitals
- Article 1
- Article 2
- Article 3
- Article 4
- Article 5
- Article 6
- Article 7
- Article 8
- Article 9
- Article 9a
- Article 10
- Article 10a
- Article 10b
- Article 10c
- Article 11
- Article 12
- Article 13
- Article 14
- Article 15
- Article 15a
- Article 16
- Article 17
ANNEX- ANNEX 1 — ESSENTIAL REQUIREMENTS
- ANNEX 2 — EC DECLARATION OF CONFORMITY
- ANNEX 3 — EC TYPE-EXAMINATION
- ANNEX 4 — EC VERIFICATION
- ANNEX 5 — EC DECLARATION OF CONFORMITY TO TYPE
- ANNEX 6 — STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES
- ANNEX 7 — CLINICAL EVALUATION
- ANNEX 8 — MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED
- ANNEX 9 — CE CONFORMITY MARKING