TOPRA and RAPS, the leading organisations focused on supporting regulatory affairs professionals working in the healthcare sector, are collaborating to facilitate this inter-regulatory and stakeholder workshop to address changes introduced by the EU Medical Device Regulation (MDR) for device-drug and drug-device ‘combination’ product authorisation. This workshop will bring together representatives of the European Commission, Member State medicinal and medical device authorities, notified bodies and industry to discuss ambiguous areas to uncover practical implementation solutions that address the implications of the new requirements.
The first half of the event will review and confirm changes in EU requirements. The second half of the event is dedicated to two interactive panel discussions addressing how the requirements could work in practice:
- Medical devices incorporating ancillary medicinal substances/human blood products
- Medicinal products incorporating medical devices as single integral products
Discussions at the meeting will be captured in one or two white papers that will be offered as input to the European Commission and Member States to support consistent interpretation and implementation of the new requirements.
The new EU MDR will impact both current and new ‘combination’ products being placed on the EU market. This event will be a unique opportunity for all stakeholders to come together to consider the changes, discuss the practical implications and contribute to possible solutions that could be considered by the regulators and authorities for consistent adoption.
Hear from leading experts, join in the discussion and ensure your organisation is prepared for the major changes ahead in this complex and converging combination product landscape.