TOPRA and RAPS Inter-regulatory and Stakeholder Workshop: Addressing the Impact of the EU Medical Device Regulation on ‘Combination’ Products
November 20, 2018 - Brussels UK
TOPRA and RAPS, the leading organisations supporting regulatory affairs professionals in the healthcare sector, are hosting this stakeholder workshop to address changes introduced by the European Union (EU) Medical Device Regulation (MDR) for device-drug and drug-device ‘combination’ product authorisation. The new EU MDR will impact both current and new ‘combination’ products being placed on the EU market and this event will be a unique opportunity to consider the changes, discuss the practical implications and put forward solutions for regulators and authorities to consider. Bringing together representatives from the European Commission, Member State authorities, notified bodies and the wider industry, it’s a chance to hear from leading experts, join in the discussion and ensure your organisation is prepared. The first half of the event will review and confirm changes in EU requirements, while the second half features two interactive panel discussions addressing the requirements’ practical implications: • Medical devices incorporating ancillary medicinal substances/human blood products • Medicinal products incorporating medical devices as single integral products Discussions at the meeting will be written up into a whitepaper that will be offered as input to the European Commission and Member States to support consistent interpretation and implementation of the new requirements. Note: Each participant must bring their own laptop to contribute to the whitepaper discussions. RAPS does not supply computer equipment for attendees.