The Federal Office for Safety in Health Care (BASG) is the authority responsible for Notified Bodies in the area of medical devices in Austria and is therefore also responsible for their designation and monitoring. Notified bodies are of crucial importance for the conformity assessment of certain classes of medical devices, as they assess whether these products meet the legal requirements and are safe and effective.

The process is divided into several steps and can be found in detail in Chapter IV of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The main points are summarized in simplified form below:

1. Application: Conformity assessment bodies that intend to become a notified body must submit an application to the BASG to initiate a designation procedure. This application must contain all the necessary information as well as evidence demonstrating compliance with the requirements of the MDR or IVDR relevant for Notified Bodies, in particular those of Annex VII. The relevant European application forms can be found on the website of the European Commission: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec14.

   For applications for designation, the documents MDCG 2021-15 together with MDCG 2021-17 (MDR) and/or MDCG 2021-16 together with MDCG 2021-18 (IVDR) must be submitted to medizinprodukte@basg.gv.at. In addition, the documents demonstrating compliance with the requirements of Annex VII MDR or IVDR must be attached.
    

2. Assessment of the application: Once the application has been received, it is reviewed by the BASG. This assessment includes the review of the submitted documents for completeness and subsequently for content. If necessary, the BASG will request additional information or documents.
    
3. On-site assessment: An important step in the designation procedure is the on-site audit. A team of experts from the BASG, together with a team of experts assembled by the European Commission, carries out an on-site assessment at the applicant body to verify whether the legal requirements have been sufficiently implemented. This essentially consists of verifying compliance with the organizational and general requirements, the quality management requirements, the availability and suitability of the necessary resources and compliance with procedural requirements (Annex VII MDR and IVDR).  
    
4. Decision on Designation: After completed assessment and auditing as well as rectification of potential non-conformities by the body, the BASG makes a decision on the designation of the body, taking into account the assessment results of the European Commission's expert team. If the assessment is positive, the designation is carried out in written and subsequently published as a european notification via the “NANDO website” (New Approach Notified and Designated Organizations) website.
    

Notified bodies are subject to continuous monitoring by the Federal Office for Safety in Health Care. The most important monitoring measures include

• Annual monitoring audit of the Notified Body, and where applicable its subsidiaries and subcontractors, to verify continued compliance with the requirement of Annex VII of the MDR / IVDR

• Observation of audits performed by the personnel of the Notified Body and, if necessary, the personnel of the subsidiaries and subcontractors

• Review of the technical documentation assessments performed by the Notified Body, in particular the clinical evaluation (MDR) and the performance evaluation (IVDR)

• Complete reassessment of the Notified Body every 5 years, with the repeated involvement of a team assembled by the European Commission
   

With regard to the fees incurred, please refer to the current Fee Regulation.
 

For further information, please contact medizinprodukte@basg.gv.at.