Demystification of notified bodies – Perspectives from the British Standards Institution

Do you work with regulatory affairs? Are you eager to learn more about notified bodies and how they work? Get insights from the notified body the British Standards Institution (BSI) and how they work with manufacturers of medical devices. What is the typical process? What are the typical mistakes and how do you avoid them as a manufacturer of medical devices?

Join the webinar that demystifies notified bodies. After the presentation, there will be a timeslot for you to ask questions.

The role of Notified Bodies is vital as they are responsible for assessing and certifying products’ compliance with the Medical Device Regulation.
The webinar starts with an overview of navigating and identifying suitable Notified Bodies based on device codes.
After the general introduction, the focus will be moved to how to approach BSI, from initial contact to the contract stage and throughout the full certification process.
Following that, the webinar will present a detailed overview of the organisational structure of BSI RS Medical Devices and the range of device technologies that can undergo assessment. The webinar will conclude with a feature presentation covering the CE marking certification process, highlighting common mistakes, and sharing key lessons learnt.

This webinar is held in English.

Program (Updated continuously)

10.00-10.05 – Welcome and introduction to the webinar
v/Marlene Højstrup Jensen, Community Manager, Danish Life Science Cluster

10.05-11.10 – Presentation: Demystification of notified bodies – Perspectives from BSI
v/Thomas Doerge, Global Head of AIMD in Regulatory Services, British Standards Institution, and Concetta Gallo, AIMD Technical Team Manager, British Standards Institution

11.10-11.30 – BSI answers your questions

11.30 – Thank you for joining the webinar

When you participate in this event, your time will be used as co-financing for the project, Innovation Program: Life Science and Eelfare technology (RFPRO-22-0042) at an hourly price of DKK 373. Therefore, we ask you to register your hours immediately after the event.

If you are from a company, we ask you to sign a de minimis declaration, an SME declaration and a partner declaration before participating in the event.

The network is co-financed by the European Union.

Register here