directive 93/42
|
Council Directive 93/42/EEC on medical devices
Council Directive 93/42/EEC on medical devices Diagnosis prevention monitoring treatment or alleviation of disease Diagnosis monitoring treatment alleviation of or compensation for injuries or handicaps Investigation replacement or modification of the anatomy or of a physiological process Conception control |
|
DEVICES DIRECTIVE (93/42/EEC) OFFICIAL JOURNAL OF MEDICAL
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169 12 7 1993 p 1) Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC (OJ L 90 I 25 3 2020 p 1) |
What is Directive 93/42/EEC?
It is for the national Competent Authorities and national Courts to take legally binding decisions on a case-by-case basis. Directive 93/42/EEC, as amended, allows for derogation from the classification rules outlined in its Annex IX in light of technical progress or on information gathered from post-market experience with the device.
What Directive 93/42/EEC reclassifies breast implants?
Directive 2003/12/EC7 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices. Directive 2005/50/EC8 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices.
When did the Medical Device Directive come into effect in Germany?
In Germany, the Directive was correspondingly converted on 2 August 1994 in the German Act on Medical Devices (MPG). This was last amended on 18 July 2017. Application of the above rules Differentiation between medical devices and other products
What is Directive 89/617/EEC?
Directive as last amended by Directive 89/617/EEC (OJ No L 357, 7. 12. 1989, p. 28). 12. Requirements for medical devices connected to or equipped with an energy source 12.1. Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use.
|
B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning
11-Oct-2007 COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. (OJ L 169 12.7.1993 |
|
Council Directive 93/42/EEC
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. THE COUNCIL OF THE EUROPEAN COMMUNITIES. Having regard to the Treaty establishing |
|
DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND
05-Sept-2007 relating to active implantable medical devices Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the ... |
|
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices. Name and address of the notified bodies. ID. Responsible for the following products. |
|
Europe-consolidated-mdd-93-42-eec.pdf
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. THE COUNCIL OF THE EUROPEAN COMMUNITIES. Having regard to the Treaty establishing |
|
REGULATION (EU) 2017/ 745 OF THE EUROPEAN PARLIAMENT
05-May-2017 (4) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169 12.7.1993 |
|
Medical Device Directive 93/42/EEC CE-Marking What
Only one name is allowed and is to be preceded by the EU Symbol for manufacturer. Conformity with Medical Device Directive 93/42/EEC is mandatory all devices |
|
MEDDEV 2.7/1 revision 4 Clinical evaluation: a guide for
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices clinical investigation application under directives 90/385/EEC and 93/42/EC. |
|
Commission Regulation (EU) No 722/2012 of 8 August 2012
08-Aug-2012 requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (3). |
|
Comparison of the articles of the European Medical Devices
The table is an excerpt from the MDR/IVDR Smart Support available in Compliance Navigator. Topic. Scope - inclusions. Medical Devices Directive. (93/42/EEC) |
|
B DIRECTIVE 93/42/CEE DU CONSEIL du 14 juin 1993 relative aux
11 oct 2007 · DIRECTIVE 93/42/CEE DU CONSEIL du 14 juin 1993 relative aux dispositifs médicaux (JO L 169 du 12 7 1993 p 1) Modifiée par: |
|
Council Directive 93/42/EEC - EUR-Lex
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES Having regard to the Treaty establishing |
|
Directive 93/42/CEE relative aux Dispositifs Médicaux - Qualitiso
5 mai 2015 · Introduction à la directive 93/42/CEE relative aux dispositifs médicaux: La dernière version consolidée est disponible au format pdf |
|
DIRECTIVE 93 42 DISPOSITIF MEDICAUX
DIRECTIVE 93/42/CEE DU CONSEIL du 14 juin 1993 relative aux dispositifs médicaux considérant que les dispositions législatives réglementai- |
|
Les directives européennes relatives aux dispositifs médicaux
La Directive 93/42/CEE qui comprend 22 articles et 12 annexes a été complétée par : • Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in |
|
Directive 93/42/CEE du Conseil du 14 juin 1993 relative aux
Directive 93/42/CEE du Conseil du 14 juin 1993 relative aux dispositifs médicaux · JOUE L 169 du 12 juillet 1993 · Textes de transposition · Appliques · Liens |
|
Passage de la directive 93/42 CEE au Règlement Européen 2017
22 jan 2020 · Directive 93/42/EEC will be replaced by Regulation 2017/745 on medical devices This report deals with the regulatory developments to be taken |
|
Medical Device Directive (MDD) Directive 93/42/EEC
Council Directive 93/42/EEC of 14 June 1993 Concerning medical devices Medical Device Directive – MDD Recitals · Article 1 — Definitions scope |
|
Medical Device Directive 93/42/EEC CE-Marking What
Conformity with Medical Device Directive 93/42/EEC is mandatory all devices that fit the definition of a 'medical device' and its accessories |
|
Directives dispositifs Médicaux - CapTronic
actifs la directive 93/42/CEE du Conseil relative aux dispositifs médicaux et la directive 98/8/CE concernant la mise sur le marché des produits biocide |
| Council Directive 93/42 concerning medical devices |
| PART 2 Modification of Annexes to Directive 93/42 |
|
NEW YORK Advance Directive - NHPCO
Advance Directive Planning for Important Healthcare Decisions CaringInfo 1731 King St , Suite 100, Alexandria, VA 22314 www caringinfo 800/658- 8898 |
|
DIRECTIVE NATIONALE DE LA SECURITE DES - DGSSI
principales actions prise consiste à élaborer et mettre en œuvre une Directive Nationale de la Sécurité des Systèmes d'Information (DNSSI) avec pour objectifs |
|
Directive - Publications du ministère de la Santé et des Services
11 fév 2021 · Directive sur la priorisation des travailleurs de la santé pour les rendez-vous de vaccination COVID-19 et des personnes proches aidantes |
|
La directive RED - ANFR
1 juil 2020 · La directive européenne 2014/53/UE dite RED (Radio Equipment Directive), harmonise les réglementations des États membres de l'Union |
|
Manuel relatif à la mise en oeuvre de la directive services
Les services exclus du champ d'application de la directive Directive 2006/123/ CE du Parlement européen et du Conseil du 12 décembre 2006 relative aux |
|
La transposition de la directive comptable unique a - Focus IFRS
la directive comptable unique 4, les micro- entreprises y sont définies par un méca- nisme de seuils nécessitant de respecter deux d'entre eux parmi les suivants |
|
La 4 e Directive Anti Blanchiment - Economiegouvfr
4e Directive anti-blanchiment et financement du terrorisme en 12 points La directive (UE) 2015/849 du Parlement européen et du Conseil du 20 mai 2015 |
|
La directive européenne « Produits de construction » - INRS
Aussi, parmi les différentes directives inté- ressant le secteur du bâtiment et des travaux publics, la directive n° 89/106/CEE du Conseil du 21 décembre 1988, dite |
