MDR requirements on combination products with focus on Art 117 & lessons learned
(Advanced course for PGS students)
31.05.2022, 10:00 am – 11:30 am
The date of application for the EU medical device regulation (MDR) is now a year ago with new requirements for medicines and devices regulatory authorities, notified bodies and manufacturers introduced as a result. So it is an ideal time to review what are the lessons learnt we in the past year and ensure that we continue to engage with all stakeholders to share experiences and best practice.
This seminar session looks at the various combination products in the EU. It will introduce the regulatory background and discusses the Notified Body experience with the MDR implementation for these types of products including:
Devices with ancillary medicinal substances (MDR Rule 14 devices). With an update on the reconsultation process / MDCG 2020-12 requirements with main focus on
Medicinal Products with integral device (MDR Article 117). Overview of process, feedback on common issues and lessons learnt.
Dr. Christiana Hofmann
From my educational background I am Biologist. It became quite soon obvious to me that my main interest is in the biomedical area. That’s why I performed my PhD at the Helmholtz Research Centre of Munich in cooperation with the Technical University of Munich in the field of Toxicology with focus on risk analysis and toxicokinetic models. During this time, I could build up my expertise in Toxicology by attending several courses of DGPT the association of toxicology specialists.
After gaining several years of experience in the pharmaceutical industry like Novartis I joined TÜV in 2016. Here I started as auditor and assessing technical documentations. After that I was leading a team of experts and auditors for non-active medical devices and recently, I am overall responsible for Article 117 and Annex XVI MDR in the DACH & Nordics region in the function of a regional manager.
What is really a perfect match for me because I can combine my passion for biomedicine, toxicology, and my experience in medical devices that I gained over the past years.
*for students of the PGS course “Toxikologie undUmweltschutz” of the University Leipzig, a reduced fee (125.00 €) will be charged