Lexparency.org
Deutsch
Español
Council Directive 93/42/EEC of 14 June 1993
Concerning medical devices
Medical Device Directive – MDD
- Recitals
- Article 1 — Definitions, scope
- Article 2 — Placing on the market and putting into service
- Article 3 — Essential requirements
- Article 4 — Free movement, devices intended for special purposes
- Article 5 — Reference to standards
- Article 6 — Committee on Standards and Technical Regulations
- Article 7
- Article 8 — Safeguard clause
- Article 9 — Classification
- Article 10 — Information on incidents occuring following placing of devices on the market
- Article 11 — Conformity assessment procedures
- Article 12 — ►M5 Particular procedure for systems and procedure packs and procedure for sterilisation◄
- Article 12a — Reprocessing of medical devices
- Article 13 — Decisions with regard to classification and derogation clause
- Article 14 — Registration of persons responsible for placing devices on the market
- Article 14a — European databank
- Article 14b — Particular health monitoring measures
- Article 15 — Clinical investigation
- Article 16 — Notified bodies
- Article 17 — CE marking
- Article 18 — Wrongly affixed CE marking
- Article 19 — Decision in respect of refusal or restriction
- Article 20 — Confidentiality
- Article 20a — Cooperation
- Article 21 — Repeal and amendment of Directives
- Article 22 — Implementation, transitional provisions
- Article 23
ANNEX- ANNEX I — ESSENTIAL REQUIREMENTS
- ANNEX II — EC DECLARATION OF CONFORMITY
- ANNEX III — EC TYPE-EXAMINATION
- ANNEX IV — EC VERIFICATION
- ANNEX V — EC DECLARATION OF CONFORMITY
- ANNEX VI — EC DECLARATION OF CONFORMITY
- ANNEX VII — EC DECLARATION OF CONFORMITY
- ANNEX VIII — STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
- ANNEX IX — CLASSIFICATION CRITERIA
- ANNEX X — CLINICAL EVALUATION
- ANNEX XI — CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES
- ANNEX XII — CE MARKING OF CONFORMITY