Medical Devices Directive
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. 
In order for a manufacturer to legally place a medical device on the European market, the requirements of the Medical Device Directive have to be met. This is done by demostrating that:
- The manufacturer has a quality management system in place
- The product meets all the applicable essential requirements in Annex I
- The Quality Management System is audited as per the specific conformity assessment route of the Medical Device Directive
At TÜV SÜD, we undertake design dossier reviews, required under the Medical Device Directive (MDD) and can issue design examination certificates, in accordance with Concil Directive 93/42/EEC, showing compliance with the relevant provisions of Annex I of the MDD. We also test and certify In Vitro Diagnostic Medical Devices, as required by Directive 98/79/EC (IVDD) and Active 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 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 (Transmissible Spongiform Encephalopathy).
Benefits of using TÜV SÜD Product Service for Medical Devices Service |
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