MDR: The Role of Regulatory Affairs in Clinical Trials

The clinical evidence of your medical device is crucial. Gain knowledge, network and discuss perspectives on the topic.

For a medical device the clinical evidence is essential and before you plan a clinical investigation you should know your device and the competition on the market.

A good clinical evaluation will provide you with the knowledge needed to limit the scope of potential clinical investigations, formulate a clinical strategy, and set up a roadmap to market – including future development of your product. Starting this work early on will save you time and money.

This track also includes perspectives on AI and Article 5.5.

Program

Program 13:30 – 13:40 Welcome and introduction to the program
by/ Marlene Højstrup Jensen, Executive PA for CEO and Business developer, Danish Life Science Cluster

13:40 – 14:05 Presentation: The Role of Clinical Trials in Regulatory Affairs
by/ Maria Lindgren, Director Clinical Strategy, Key2Compliance

The presentation will give an overview of how and why collecting clinical data for medical device. Perspectives and examples of clinical studies from the manufacturer perspective, both investigator-led and sponsor-led studies. It will also cover lessons learned from Notified Body clinical review under MDR

14:05 – 14:30 Questions and discussion

14:30 – 14:45 Break & network

14:45 – 15:10 Presentation: Tüv Süd Denmark (Notified Body)
by/ Theresa Larriba Harboe, Head of Client Relations, TÜV SÜD

Have you always considered how to approach a Notified Body? How early should you get in touch? And is there a Notified Body in Denmark still?
All of these questions will be part of the presentation of the Danish Notified Body TÜV SÜD DK MHS. We will describe our service offerings and how we work with conformity assessments. We will also touch upon how we see the collaboration between Legal manufacturer and Notified Body.

15:10 – 15:30 Questions and discussion

15:30 – 15:55 Speeddating – Learn new people and perspectives

16:00 Thank you for today