Last week ULG hosted a webinar on the language-specific requirements of the European Union’s new Medical Device Regulation (MDR).
Renowned MDR expert, Ronald Boumans, discussed key language-specific areas that global organizations must be aware of to ensure they are labeling devices correctly under the new legislation, which goes into effect in 2020.
You can access the recording of the presentation here.
Download a PDF of the slides here.
Device Labeling: What Goes Where?
Ronald detailed key information that must be included on devices under the new regulation and discussed where that data must be stored. He also outlined the general principles of labeling for the 24 European languages that are applicable under the legislation, noting the risks and opportunities inherent in label design.
Key webinar discussion points included:
- The difference between language-sensitive, non-language-sensitive and possibly language-sensitive information
- The importance of correctly identifying and creating appropriate messaging for a label’s intended readers
- Health and safety information that will be required on labels
- The European Database on Medical Devices (EUDAMED)
Are You Ready For Compliance?
Though 2020 seems like a long while off, with 24 applicable European languages to consider, it isn’t too early to start preparing for the European Union’s Medical Device Regulation. Visit our content library for additional MDR information, or contact Jackie Weber directly at jacqueline.weber@ulgroup.com.
