MARACA International participated in the annual Safe-N-Medtech OITB consortium meeting in Barcelona. Dr. Luc Van Hove presented the work package
This regulatory roadmap for nanotechnology-based medical devices and IVDs is the same as for conventional medical devices and IVDs. However, for the nanotechnology-based devices additional analytical performance characterization, biocompatibility testing, risk management and labelling are required. The different regulatory steps are highlighted, as well as the current challenges, such as incomplete intended purpose statements, what biocompatibility testing is needed 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. The impact of the REACH and CLP regulations on labeling will also be highlighted.
When you are developing nanotechnology-based devices this webinar “Nanotechnology-based medical device registration roadmap for Europe” is a must for you to stay compliant with the current European regulations.
“Nanotechnology-based medical devices require special attention to biocompatibility testing.”
Dr. Luc Van Hove of MARACA International will train the Safe-N-MedTech consortium partners on the regulatory requirements in Europe for biological toxicity testing of nanotechnology-based medical devices. This training is an introduction to the Medical Device Regulation 2017/745 and the REACH Regulation 1907/2006, last amended in 2021, which specify how nanotechnology-based medical devices need to be handled. The training will then introduce the EN ISO 10993 series of harmonized standards. It starts with the review of the current version of EN ISO 10993-01:2020. The focus will be on defining the list of the chemical components of the final product and on developing the biological toxicity risk documentation. Depending on the location and duration of the contact with the patient and on the toxicity of the component a set of biocompatibility tests will have to be performed. For nanotechnology-based medical devices these harmonized standards are applicable. However, due to the nature of the nanomaterials the general information of the standards are not sufficient and specific tests might have to be developed. Hence, special attention needs to be paid to biocompatibility testing for nanotechnology-based medical devices.