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Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998
On in vitro diagnostic medical devices
- Recitals
- Article 1 — Scope, definitions
- Article 2 — Placing on the market and putting into service
- Article 3 — Essential requirements
- Article 4 — Free movement
- Article 5 — Reference to standards
- Article 6 — Committee on Standards and Technical Regulations
- Article 7
- Article 8 — Safeguard clause
- Article 9 — Conformity assessment procedures
- Article 10 — Registration of manufacturers and devices
- Article 11 — Vigilance procedure
- Article 12 — European databank
- Article 13
- Article 14 — Amendments to Annex II, and derogation clause
- Article 15 — Notified bodies
- Article 16 — CE marking
- Article 17 — Wrongly affixed CE marking
- Article 18 — Decisions in respect of refusal or restriction
- Article 19 — Confidentiality
- Article 20 — Cooperation between Member States
- Article 21 — Amendment of directives
- Article 22 — Implementation, transitional provisions
- Article 23
- Article 24
ANNEX- ANNEX I — ESSENTIAL REQUIREMENTS
- ANNEX II — LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3)
- ANNEX III — EC DECLARATION OF CONFORMITY
- ANNEX IV — EC DECLARATION OF CONFORMITY
- ANNEX V — EC TYPE-EXAMINATION
- ANNEX VI — EC VERIFICATION
- ANNEX VII — EC DECLARATION OF CONFORMITY
- ANNEX VIII — STATEMENT AND PROCEDURES CONCERNING DEVICES FOR PERFORMANCE EVALUATION
- ANNEX IX — CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES
- ANNEX X — CE MARKING OF CONFORMITY