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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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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.
Benefits
Manufacturers / distributors use the technical expertise of the certification organisation and develop the legal basis to market medical devices freely within Europe.
Validity of Swiss certifications under accreditation in Switzerland and abroad
You are currently discussing the legal uncertainty regarding the export of medical devices to the EU under the previous law under the MRA CH-EU. This affects, among other things, the EU's recognition of certificates for legacy medical devices that benefit from the transitional periods in the EU. For further information on the export of legacy medical devices to the EU, please contact SECO and Swissmedic.
The validity of Swiss certifications under SAS accreditation is not affected by this. Such certification documents, e.g. for the international standards ISO 9001, ISO 14001, ISO 45001, ISO 13485, ISO 22000, retain their current validity in Switzerland and abroad.
Requirements
(EU) 2017/745 / ISO 13485:2016 / ISO 9001:2015 / ISO 14971:2019
Authorisation to market a medical device requires fulfilment of the following general requirements:
- Patient, user and personal safety
- Realisation of integrated safety and recognised state of the art
- Performance data and performance effectiveness of the product
- Reliability of the product (over its entire service life)
- Consideration of storage and transport conditions
- Risks from undesirable side effects
Network
The certification body of the Swiss Safety Center is a member of the SWISS MEDTECH association.
The certification body of the Swiss Safety Center is involved in the following standards committees:
INB/NK 0129 "Implants for surgery"
INB/NK 0155 "Dentistry"
INB/NK 0171 "Sterilizers and Sterilization"
INB/NK 2205 "Non-active medical devices"
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