European Medical Devices Industry

Guiding light emitted by a lighthouse. Digital illustration. © Andrea Danti - Fotolia The implementation of Community legislation on medical devices lies with the Member States. The guidelines for medical devices en ) établissent des procédures spécifiques auxquelles les autorités compétentes doivent se conformer lorsqu'elles considèrent qu'un dispositif médical est dangereux et doit être retiré du marché («clause de sauvegarde») ou lorsque le marquage CE est apposé de manière injustifiée sur un dispositif médical ou en est absent («marquage CE indûment apposé»). English (en) establish specific procedures which the competent authorities must follow when they consider that a medical device is dangerous and must be removed from the market ("safeguard clause") or where the CE marking is affixed unduly on a medical device or is absent ("CE marking affixed unduly").

Market surveillance

The role of the Commission is to ensure where appropriate that all these measures are applied within the Community. In addition, Member States may, for reasons of health, to define requirements for the withdrawal from the market or the placing on the market of a medical device or a group of medical devices given ("Special Measures Health Monitoring "). Ideally, these measures should be community action.

Vigilance

The main objective of the vigilance system for medical devices is to protect the health and safety of patients, users and third parties by reducing the likelihood of repetitive incidents related to the use of a medical device. To this end, guidelines for medical devices include an assessment of the incident and, if appropriate, dissemination of this information in the form of a report by the national competent authorities (NCAR) in order to avoid the recurrence of such incidents.

  • For more information on NCAR reports, use the following link: vigilance reports en ) English (en)

Eudamed

Eudamed en ) est la banque de données européenne des dispositifs médicaux. English (en) is the European databank for medical devices. Strengthen market surveillance and transparency in the field of medical devices providing competent authorities of the Member States to have a quick access to information, and it is intended to contribute to the uniform application of guidelines, including regarding the requirements for registration.

2003-10-02 06:38:37 by apathetichuman

Sorry for the delay

Had to sleep. Okay, not what you asked for, but, along the same lines. I will find the cream connection and post it later. These articles are all about the companies that pay lots of money for foreskin harvesting. Granted, some of their discoveries are for the betterment of medicine. However, they are all motivated by foreskin for money.
Don't believe it ? Read for yourself - directly from the companies involved - all about the massive foreskin-for-sale industry !
Periscope: Bionic Band-Aid
Newsweek Wednesday, January 13, 1999
Living Human Skin Equivalent Apligraf
Molecule of the Month February 1998
Bioengineered skin wins approval from the FDA
Wound Care newsletter July 1998
The Role of Tissue Engineering in Wound Care
AVF Newsletter American Venous...

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