Article 117



Bear the Challenge of the MDR Requirement

The new Regulation 2017/745 (EU) on Medical Devices (MDR) imposes strict demands on medical device manufacturers, Notified Bodies, and extends the scope also to the pharmaceutical industry related to medicinal substances with an integral medical device. Article 117 of the MDR amends the Directive 2001/83/EC, point 12 of Section 3.2 and requests for (single) integral products the involvement of a notified body to assess the conformity of the device part with the relevant general safety and performance requirements (GSPR) of Annex I and to issue a so-called “Notified Body Opinion”. This webinar will highlight the current experience with the new obligations, and the necessary steps to obtain a Notified Body Opinion. 

Key topics covered:

  • Learn the impact of Article 117 on the concentrated product portfolio

  • Understand key general safety and performance requirements

  • Prepare your document for submission


Dr Thomas MaierMs. Julia Frese
Division Head of Medical Services and Health Services, 

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 organisation. She is also the co-chair of Team NB working group for Article 117.

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


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