Decoding Article 117 of the EU MDR

Comply with MDR article 117

Medical device manufacturers, notified bodies, and the pharmaceutical industries involved in a single integral drug-device combination product's development must be aware of the impact of the Medical Device Regulation Article 117.

This webinar will explore what will change when MDR is applicable, the most recent experience with the new obligations, and essential steps to obtain a Notified Body Opinion.

Complete the form to view the on-demand webinar!

Key topics covered:

• The impacts of Article 117 on the product portfolio

• Essential safety and performance requirements

• How to prepare documentation for the first submission

• Change Management concepts applied for medical devices

 ABOUT THE SPEAKER

Ms. Julia Frese

Division Head of Medical Services and Health Services, TÜV SÜD Japan

Julia is a biomedical engineer with a Master degree in Business Administration. Julia gained experience in development, regulatory approval of combination devices and ATMP products. She was also involved in the development of standards for ATMP products.

Currently, Julia is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of Article 117 service within the organization. She is also the co-chair of Team NB working group for Article 117.

Related Services: Medical Device Regulation (MDR) | EU In Vitro Diagnostic Medical Device Regulation (IVDR) | Medical Device Single Audit Program (MDSAP)