The regulatory roadmap for the European registration of nanotechnology-based medical devices and IVDs is presented. This regulatory roadmap is the same for conventional medical devices and IVDs as for nanotechnology-based medical devices or IVDs. However, for the latter additional analytical performance characterization, risk management and labelling are required.
The different regulatory steps are highlighted, as well as the current challenges, such as incomplete intended purpose statements and what is sufficient clinical evidence. Many small medical device and IVD companies are not well prepared for the transition to the new regulatory requirements.
The key steps of the regulatory roadmap are reviewed: Manufacturer’s role, scientific validity, analytical performance, clinical performance, clinical evidence, clinical performance report, post-market clinical follow-up, conformity assessment, GSPRs, certificates and EUDAMED registration.
Participants will learn what the required regulatory steps are for the development of a nanotechnology-based medical device and IVD in compliance with the MDR and IVDR regulations. When you are developing nanotechnology-based devices, this webinar is a must for you to stay compliant with the current regulations.
Key Learning Objectives
- Develop a compliant Intended Purpose statement
- Determine sufficient clinical evidence for your device
- Develop a compliant Clinical Evaluation Report
- Run systematic Literature reviews
- Medical Device and IVD companies developing nanotechnology-based, medical Devices and IVDs
- Director of R&D
- Quality Director
- Regulatory Director
- Senior Management
- Head of Business Development