When: Wednesday, June 13
Time: 9:00 a.m. – 9:45 a.m. CST
What’s language got to do with the EU’s new Medical Device Regulation (MDR)?
As it turns out, everything.
There are 24 official languages in the European Union (EU), and in May of 2020 the EU will require all medical devices to include user information in the national language of the territories where they are sold. There are very specific language requirements to become familiar with and not as much time as it seems to get started.
What to Expect From This Webinar
- The difference between language-sensitive, not language-sensitive and possibly language-sensitive information and how these requirements will affect medical device labeling
- Presenter Ronald Boumans will be answering questions from attendees, which you may submit prior to the webinar on the registration page
Who Should Attend
Anyone involved in the medical device industry is encouraged to attend this webinar, especially those who are involved in the manufacture, distribution or import of these devices.
About the Presenter: Ronald Boumans
Ronald Boumans has more than 25 years of experience in the medical device sector. He has served as an Inspector for the Dutch Healthcare Inspectorate, the Competent Authority for The Netherlands and a trainer at the Dutch Inspection Academy. He has represented The Netherlands in several working groups at the European Commission, such as the Compliance and Enforcement (COEN) and the Medical Device Expert Group (MDEG) for borderline devices and classification. He was also involved in the first impact assessments of the MDR/IVDR.
Ronald joined global medical device consulting firm Emergo in 2013 to focus on European medical device consulting. On behalf of Emergo, he sits on the executive board of the European Association of Authorized Representatives (EAAR). He represents the EAAR in several working groups at the European Commission, including the new EUDAMED Steering Committee and several of its working groups, such as on post-market surveillance, vigilance and data exchange.