Medical devices
| Title | Link |
|---|---|
| Council Directive 93/42/EEC of 14 June 1993 concerning medical devices | http://europa.eu.int/eur-lex/en/lif/dat/1993/en_393L0042.html |
| Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices | http://europa.eu.int/eur-lex/en/lif/dat/1990/en_390L0385.html |
| Swissmedic - Guide to the regulation of medical devices | http://www.swissmedic.ch/md/files/leitf-e.html |
| Ordonnance du 24 janvier 1996 sur les dispositifs médicaux (ODim); RS 819.124 | http://www.admin.ch/ch/f/rs/8/819.124.fr.pdf |
| Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Devices Directive, Article 10 | http://www.bag.admin.ch/md/pdf/ivdform-fe.pdf |
| Form for the registration of information relating to certification of In Vitro Diagnostic Medical Devices (Annexes III to VII) - In Vitro Diagnostic Medical Devices Directive | http://www.bag.admin.ch/md/pdf/ivdzert-fe.pdf |
| Normes techniques pour les dispositifs médicaux - Ordonnance sur les dispositifs médicaux (ODim) | http://www.bag.admin.ch/md/pdf/normenf.pdf |
| Liste des numéros d’identification des organes responsables de l’évaluation de la conformité des dispositifs médicaux reconnus en Suisse (articles 8 et 11 ODim) July 3, 2001 | http://www.bag.admin.ch/md/pdf/kbs-f.pdf |
| Notification according to art. 6 MDO - one notification for each device or group of devices. | http://www.bag.admin.ch/md/pdf/me-formdfie.pdf |
| Dispositifs médicaux: annonce des incidents par les utilisateurs | http://www.bag.admin.ch/md/pdf/vi_factf.pdf |
| Edward M. Basile, Ellen Armentrout & Kelly N. Reeves, Medical Device Labeling and Advertising: An Overview, 54 Food and Drug Law Journal 519-534 (1999) - (16 pages) | http://www.fdli.org/pubs/Journal%20Online/54_4/art2.pdf |
| Medical Devices Ordinance (MDO) Information on Article 13 Reporting of serious incidents | http://www.bag.admin.ch/md/pdf/VI-Indus-InfoE.pdf |
| Check list of documents required - Annonce d'investigations cliniques avec des dispositifs médicaux | http://www.bag.admin.ch/md/pdf/kl-checklistdfie.pdf |
| European Committee for Standardization - CEN - home page | http://www.cenorm.be/ |
| The International Organization for Standardization (ISO) - home page - "a non-governmental organization" & "a worldwide federation of national standards bodies from some 140 countries, one from each country". | http://www.iso.ch/iso/en/ISOOnline.openerpage |
| FDA, Devices classification - previous correspondance | http://www.fda.gov/cdrh/devadvice/21.html#contents |
| FDA - Product Code Classification Database | http://www.fda.gov/cdrh/prodcode.html |
| FDA - Good Manufacturing Practices (GMP) / Quality System (QS) Regulation | http://www.fda.gov/cdrh/devadvice/32.html#contents |
| FDA - CDRH Annual Report Fiscal Year 2000 | http://www.fda.gov/cdrh/annual/fy2000/annualreport-2000.pdf |
| FDA - Breast Implants - An Information Update - 2000 - (82 pages) | http://www.fda.gov/cdrh/breastimplants/indexbip.PDF |
| John Y. Chai, Medical Device Regulation in the United States and the European Union: A Comparative Study, 55 Food and Drug Law Journal 57-80 (2000), | http://www.fdli.org/pubs/Journal%20Online/55_1/art4.pdf |
| Draft - Ordonnance sur les dispositifs médicaux - Odim | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/mepv.pdf |
| Rapport explicatif concernant l’ordonnance sur les dispositifs médicaux - Odim - Project of September 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/mepv_erl.pdf |
| Linda R. Horton - Medical Device Regulation in the European Union - 50 Food and Drug Law Journal 461-476 (1995) - (16 pages) | http://www.fdli.org/pubs/Journal%20Online/50_3/art11.pdf |
Back to products: therapeutic products
Last updated: July 8, 2002