Let’s unleash “MDR Classification surprises” [MDR 2017/745]
Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share his knowledge as he worked on the consultation of this guidance and he can tell us if there are some specific elements to look at. The discussion of today will be mainly on the changes related to the new EU MDR 2017/745. We will also discuss a bit of the EU MDD 93/42/EC
Who is Frank Matzek?
Frank Matzek is a Medical Device expert with 40 years of experience. He worked within a Test and Certification body called BerlinCert where he was the technical expert. Then he entered BIOTRONIK as Regulatory Affairs Manager and didn’t leave it until now. He is now the Vice-President of Regulatory & Government affairs. Additionally, Frank is also part of the BVMed as a member and vice-chair of the Regulatory Affairs Committee (AKRA) and lastly member of the MedTech Europe.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses…
Links from the Video
- Frank Matzek Profile: https://www.linkedin.com/in/frank-matzek-a43617/
- Biotronik website: https://www.biotronik.com/?campaign=linkedinus
- MDCG 2021-24: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
- MEDDEV classification guidance: https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native