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Medical Device Directive 93/42/EWG (MDD) - Johner …
- https://www.johner-institute.com/articles/regulatory-affairs/medical-device-directive/
- Medical Device Directive 93/42/EWG (MDD) The MDD is the Medical Device Directive or 93/42/EEC. The number indicates the year of initial release (1993) and the consecutive number of directives in that year. European national states must translate this directive …
B COUNCIL DIRECTIVE 93/42/EEC of 14 June …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
- COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the …
Medical Device Directive (MDD), Directive 93/42/EEC - Lexparency
- https://lexparency.org/eu/31993L0042/
- Medical Device Directive (MDD), Directive 93/42/EEC Concerning medical devices Medical Device Directive – MDD Recitals Article 1 — Definitions, scope Article 2 …
EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042
- Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on …
Council Directive 93/42/EEC of 14 June 1993 concerning …
- https://www.legislation.gov.uk/eudr/1993/42/2020-12-31
- Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable …
ANNEX IX Medical Device Directive - CLASSIFICATION …
- https://lexparency.org/eu/31993L0042/ANX_IX/
- ANNEX IX Medical Device Directive - CLASSIFICATION CRITERIA ANNEX IX — CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the classification rules …
Post-Market Surveillance & Vigilance
- https://www.johner-institute.com/articles/regulatory-affairs/and-more/post-market-surveillance/
- a) Medical Device Directive (MDD, 93/42/EWG) The Medical Device Directive (MDD) explicitly requires (Appendix IX, clinical evaluation): manufacturers must update the clinical …
EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/PL/TXT/?uri=CELEX%3A31993L0042
- dyrektywa Rady 90/385/EWG z dnia 20 czerwca 1990 r. w sprawie zbliżenia ustawodawstw Państw Członkowskich odnoszących się do wyrobów medycznych aktywnego …
EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:31993L0042
- Gehört zu den Bestandteilen eines Produkts ein Stoff, der bei gesonderter Anwendung als Arzneimittel im Sinne des Artikels 1 der Richtlinie 65/65/EWG angesehen werden und …
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