During the meeting we will discuss regulatory updates regarding the registration process of medical devices (MDR) and in particular in vitro medical devices (IVDR). We will discover the necessary steps to submit certification requests to notified bodies (NB) proposing winning strategies to keep up with the deadlines set by Regulation 2023/607. Finally, we will provide an overview of the current European situation.

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Target group

• Quality and RA Manager
• R&D
• Company managers

What we learn from the webinar

• IVDR – current situation Italian market and NB
• MDR focus on Regulation 2023/607 – MDD extension mode
• Testing active medical devices – activity promotion IMQ laboratories
• How IMQ wants to support companies in keeping up with the times: IMQ MED UP

Program

We will talk about the current regulatory situation at the beginning of 2024 on the subject of IVDR and MDR to understand the critical issues and necessary actions to be taken to comply with the deadlines dictated by Regulation 2023/607. It is essential to understand the stages within which manufacturers must send applications to the NB and the European situation.
Specifically we will talk about the Active medical device world to treat the continuous regulatory update of the standards for electrical safety and electromagnetic compatibility and what IMQ laboratories can offer.
This is linked to the new format launched by IMQ (IMQ MED UP) with the aim of offering a tool to companies to stay up to date in the regulatory field.

Lecturer

Andrea Santoleri. Andrea Santoleri is the current Sales Manager of the Medical Devices Division of IMQ Spa.
Biomedical engineer, he graduated from Politecnico di Milano with a specialization in Cells, Tissues and Biotechnology and a thesis at the University of Arizona in the field of microfluidics.

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