Following the success of the first inaugural RMD Symposium in Prague in October 2016, this second conference, in Berlin, addressed important updates for Medical Device manufacturers, following publication of the new Medical Device and IVD Regulations in May 2017, which become mandatory in May 2020 and 2022 respectively.

In conjunction with EAAR (European Association of Authorized Representatives), the panel of experienced professionals in this field covered topics that included:

• New Regulations: strengthening the rules on placing medical devices on the market
• Reinforcement of post-market surveillance
• Improvements in traceability throughout the supply chain
• The EUDAMED database
• Authorized Representative vs Qualified Person
• Specific IVD issues

DLC’s VP, Quality and Regulatory, Roger Gray, spoke during the first day of the conference, on the changes from ‘Essential Requirements’ in the current legislation to ‘General Safety and Performance Requirements’ in the new regulations.