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Medical devices
Manufacturers of medical devices face a wide range of challenges. The market is characterised by rapid innovation and progress. Manufacturers of medical devices must fulfil their responsibilities to a particularly high degree in order to ensure the greatest possible benefit for patients.
The Swiss Safety Center certifies the quality management of organisations in accordance with ISO 13485.
As part of the conformity assessment, we work together with notified bodies in the EU to fulfil the increased and constantly changing requirements.
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Contact
Sabrina Frahmann
Deputy Head of Certification Body, Accreditation Officer, Head of MedTech
E-Mail: sabrina.frahmann@safetycenter.ch
Medical devices may only be placed on the market in the European Economic Area under certain conditions. The marketing of such products requires CE labelling. This mark may only be affixed by the distributor to Class I devices that are neither sterile nor equipped with a measuring function, after prior notification to the national authority. For all other devices, a Notified Body (NB) must be involved. This NB is authorised by the national authority for the certification of medical devices.
The marketing of medical devices is only possible in cooperation with the authorities and a notified body. The requirements to be fulfilled are set out in the Medical Devices Directive (EU) 2017/745. In addition to detailed product documentation, providers must define and document the procedures for product testing, clinical evaluation and market surveillance. These processes are thoroughly checked by the authority or the NB during the required monitoring before a certificate can be issued and the CE mark affixed.
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