In Austria, there has been no notified body in the medical device sector since 2017.

The notified bodies designated under the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation can be found in the NANDO database.

The contact person for this topic is Mr. Alexander Billasch.

Certification of medical devices

Medical devices and in vitro diagnostic (IVD) devices are subject to different conformity assessment procedures depending on their classification. The aim of the procedure is the manufacturer’s declaration of conformity – and the authorization to place the product on the market with CE marking.

The experts at INOSOLVE support you as a manufacturer in the approval process for medical devices and in vitro diagnostics. We accompany you in the planning and implementation of such projects, create the necessary documents or evaluate the existing documentation.

If your product is a medical device of risk class Is, Im, IIa, IIb and III, as well as IVD according to Directive 98/79/EC Annex II or for self-testing, the involvement of a Notified Body in the conformity assessment is required. The INOSOLVE experts can take over the coordination with the notified body if required.

The basis of the certification is ISO 13485. This standard provides an international standard for demonstrating an effective quality management system for medical device manufacturing companies. If you do not yet have this certification, the INOSOLVE experts will be happy to assist you in introducing it.

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ISO13485 affects all companies in the supply chain or the placing on the market of products regulated by the relevant EU regulations for medical devices and in vitro diagnostic medical devices.

The conformity assessment procedures required in Europe state that for medical devices to be approved, their safety and functionality must be demonstrated. Therefore, ISO 13485 is an important standard for the implementation of the system requirements according to the regulations in Europe (MDR, IVDR).