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Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)
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- 1990 No. 385
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- Revised 11/10/20070.15 MB
- Revised 20/11/20030.11 MB
- Revised 02/08/19930.22 MB
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Article 1.(1) This Directive shall apply to active implantable medical devices....
Article 2.Member States shall take all necessary steps to ensure that...
Article 3.The active implantable medical devices referred to in Article 1(2)(c),...
Article 4.(1) Member States shall not create any obstacle to the...
Article 5.(1) Member States shall presume compliance with the essential requirements...
Article 6.(1) Where a Member State or the Commission considers that...
Article 7.(1) Where a Member State finds that the devices referred...
Article 8.(1) Member States shall take the necessary steps to ensure...
Article 9.(1) In the case of devices other than those which...
Article 9a.(1) A Member State shall submit a duly substantiated request...
Article 10.(1) In the case of devices intended for clinical investigations,...
Article 10a.(1) Any manufacturer who, under his own name, places devices...
Article 10b.(1) Regulatory data in accordance with this Directive shall be...
Article 10c.Where a Member State considers in relation to a given...
Article 11.(1) Member States shall notify the Commission and the other...
Article 12.(1) Devices other than those which are custom made or...
Article 13.Without prejudice to Article 7 where a Member State establishes...
Article 14.Any decision taken pursuant to this Directive to refuse or...
Article 15.(1) Without prejudice to the existing national provisions and practices...
Article 15a.Member States shall take appropriate measures to ensure that the...
Article 16.(1) Before 1 July 1992, Member States shall adopt and...
Article 17.This Directive is addressed to the Member States.
1. The devices must be designed and manufactured in such a...
2. The devices must achieve the performances intended by the manufacturer,...
3. The characteristics and performances referred to in sections 1 and...
4. The devices must be designed, manufactured and packed in such...
5. Any side effects or undesirable conditions must constitute acceptable risks...
5a. Demonstration of conformity with the essential requirements must include a...
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
6. The solutions adopted by the manufacturer for the design and...
7. Implantable devices must be designed, manufactured and packed in a...
8. Devices must be designed and manufactured in such a way...
9. The devices must be designed and manufactured in such a...
10. Where a device incorporates, as an integral part, a substance...
11. The devices and, if appropriate, their component parts must be...
13. When a device or its accessories bear instructions required for...
14. Every device must bear, legibly and indelibly, the following particulars,...
15. When placed on the market, each device must be accompanied...
16. Confirmation that the device satisfies the requirements in respect of...
1. EC type-examination is the procedure whereby a notified body observes...
2. The application for EC type-examination shall be made by the...
3. The documentation must make it possible to understand the design,...
5. Where the type meets the provisions of this Directive, the...
6. The applicant shall inform the notified body which issued the...
1. EC verification is the procedure whereby the manufacturer or his...
2. The manufacturer or his authorized representative established within the Community...
3. The manufacturer shall, before the start of manufacture, prepare documents...
4. The manufacturer shall undertake to institute and keep updated a...
5. The notified body shall carry out the appropriate examinations and...
6.1. Manufacturers shall present the products manufactured in the form of...
6.2. A random sample shall be taken from each batch. Products...
6.3. Statistical control of products will be based on attributes and/or...
6.4. Where batches are accepted, the notified body shall affix, or...
6.5. The manufacturer or his authorized representative shall ensure that he...
STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES
1. The manufacturer or his authorized representative established within the Community...
3. The manufacturer shall undertake to keep available for the competent...
4. The information included in the declarations covered by this Annex...
5. For custom-made devices, the manufacturer must undertake to review and...
1.1. As a general rule, confirmation of conformity with the requirements...
1.2. Clinical investigations shall be performed unless it is duly justified...
1.3. The clinical evaluation and its outcome shall be documented. This...
1.4. The clinical evaluation and its documentation must be actively updated...
1.5. Where demonstration of conformity with essential requirements based on clinical...
1.6. All data must remain confidential unless it is deemed essential...
2.3.1. Clinical investigations shall be performed according to an appropriate state...
2.3.2. The procedures utilized to perform the investigations shall be appropriate...
2.3.3. Clinical investigations shall be performed in circumstances equivalent to those...
2.3.4. All appropriate features, including those involving the safety and performances...
2.3.5. All serious adverse events must be fully recorded and immediately...
2.3.6. The investigations shall be performed under the responsibility of an...
2.3.7. The written report, signed by the responsible medical specialist, shall...
MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED
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