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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 …
ANNEX II — EC DECLARATION OF CONFORMITY - Lexparency
- https://lexparency.org/eu/31993L0042/ANX_II/
- ANNEX II — EC DECLARATION OF CONFORMITY. The manufacturer must ensure application of the quality system approved for the design, manufacture and final …
Council Directive 93/42/EEC of 14 June 1993 concerning medical …
- https://www.legislation.gov.uk/eudr/1993/42/2020-12-31
- Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the …
EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042
- Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive …
Council Directive 93/42/EEC of 14 June 1993 concerning …
- https://www.legislation.gov.uk/eudr/1993/42/contents
- 1993 No. 42 Table of contents Table of Contents Content More Resources Plain View Print Options What Version Latest available (Revised) Original (As adopted by EU) Opening …
Medical Device Directive (MDD), Directive 93/42/EEC - Lexparency
- https://lexparency.org/eu/31993L0042/
- Medical Device Directive – MDD. Recitals. Article 1 — Definitions, scope. Article 2 — Placing on the market and putting into service. Article 3 — Essential …
MDD ANNEX II – EC DECLARATION OF …
- https://www.presentationeze.com/presentations/medical-device-validation/medical-devices-directive-mdd-9342eec-explained/medical-device-directive-annex-ii-ec-declaration-conformity/
- MDD ANNEX II – EC DECLARATION OF CONFORMITY (Full Quality Assurance System) The EC declaration of conformity is the procedure whereby the manufacturer …
Column - MDD – Annex II - MedTech Intelligence
- https://www.medtechintelligence.com/column/devine-guidance-mdd-annex-ii/
- Annex II (EC Declaration of Conformity – full quality assurance system) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the …
Medical Device Directive (MDD)
- https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
- Annex II or Annex III + V Choose Notified Body A certification body is a third-party company who is accredited by an organization like ANAB (http://bit.ly/ANABorg), UKAS …
Council Directive 93/42/EEC of 14 June 1993 concerning …
- https://www.legislation.gov.uk/eudr/1993/42/annex/I/division/II/division/10
- The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC. U.K. ( 1 )
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