Regulatory Affairs for Medical Devices

Team Regulatory Affairs for Medical Devices/IVDs

Navigating the regulatory landscape can be challenging. We offer consulting and regulatory support for the development of medical devices, the preparation of clinical trials for medical devices, and performance studies for in vitro diagnostics.

Regulatory consulting for your clinical investigation/performance study

The Regulatory Affairs team for medical devices/IVDs offers regulatory consulting, planning, and support for the development and submission process for clinical investigations of medical devices/performance studies of IVDs.

The service is tailored to your specific requirements in a personal consultation and includes the following areas:

• Provision of proven and compliant templates
• Review of the technical documentation required for submission to the ethics committee and national authority.
• Creation of a targeted intended purpose for your investigational device
• Determination of the risk class in accordance with the applicable classification rules and guideline documents
• A comprehensive risk analysis in accordance with EN ISO 14971
• Preparation of the necessary technical documentation for your investigational device for submission to the ethics committee and national authority (BASG)
• Consulting and support during the submission process to the national authority until a positive implementation decision is issued

Teaching and speaking activities

Continuing professional development and knowledge transfer are an integral part of our work. Our team is happy to share its knowledge in the field of clinical investigations and performance studies.

Our services include internal training events as part of staff development seminars, as well as teaching activities in various degree programs at the Medical University of Vienna and external institutions.

Templates for download

We offer the following templates for free download to employees of MedUni Vienna:

• Clinical investigation plan
• Investigator's brochure
• Regulation (EU) 2017/745 - Annex I General safety and performance requirements

Test laboratory

As part of a personal consultation, we would be happy to provide you with information about medical device safety in accordance with IEC 60601-1, the fundamentals of electromagnetic compatibility in accordance with IEC 60601-1-2, insulation coordination requirements, and our portfolio of tests for medical electrical equipment in accordance with IEC 60601-1.

We are happy to help you comply with the essential safety and performance requirements according to MDR 2017/745 Annex I and support you in finding suitable partner laboratories.