CE Marking for Medical Devices
Medical Device CE Mark
TÜV SÜD Product Service is a leading certification company and offers support to medical device manufacturers in CE Marking their products. We are accredited to assess all types of medical devices.
We undertake design dossier reviews, required under the Medical Device Directive (MDD) and can issue design examination certificates, in accordance with Council Directive 93/42/EEC, showing compliance with the relevant provisions of Annex 1 of the MDD. We also test and certify In vitro Diagnostic Medical Devices, as required by Directive 98/79/EC (IVDD) and Active Implantable Medical Devices as required by Directive 90/385/EEC (AIMD).
As a Notified Body that is undertaking clinical assessments and product testing of all medical devices we are able to assess high-risk devices with animal origin and human origin components. In each case, we prepare a detailed evaluation report assessing the risk analysis, risk management strategy and when applicable, methods applied for inactivation of TSE agents (Transmissible Spongiform Encephalopathy).
In addition to medical devices services, TÜV SÜD Product Service provides a full range of testing, certification and training solutions with specific medical and health experience in:
Benefits of using TÜV SÜD Product Service for medical devices service |
|
