PRISYM ID to present at the EU MDR Virtual Conference
PRISYM ID will be presenting at this year’s MedTech Intelligence, Virtual Conference on 23rd and 24th May 2019.
The virtual conference will explore various topics including: what the EU intend to accomplish through changes in labeling, IFU, UDI and EUDAMED; the comparison of labeling under MDD and MDR; required label contents; language requirements; UDI placement; currently unresolved potential differences between EU, FDA, and other UDI field formats and relations; the UDI database – status and procedures; establishment of EUDAMED under MDD and underline the EUDAMED implementation and enforcement timeline.
On Thursday 23rd May, Mark Cusworth, VP Research and Development at PRISYM ID will be taking part in a speaker slot between 11:00am – 12:00pm to discuss ‘Labeling and Regulatory Requirements’. The session will highlight:
- Comparison of labeling under MDD and MDR
- Required label elements
- Sterile barrier system labeling requirements
- Warnings and precautions
- Reprocessing cycles for single-use devices
- Need for package and label redesign
- Private labeling
- Deadlines and strategy
- FDA labeling guidance and EU MDR
Additionally, at 1:30pm – 2:30pm, Mark will also present within the ‘Labeling Implementation’ session and discuss strategies and procedures for effective and efficient labeling changes, how to coordinate EU MDR labeling changes with other global labeling requirements and implementing systems to manage this process.
The EU MDR poses tremendous economic and practical challenges for manufacturers. With deadlines looming, lingering ambiguities and limited availability of notified body support, companies are struggling with implementation.
About the speaker
Mark Cusworth, VP Research and Development, PRISYM ID
Mark has over 15 years of experience heading up a team providing off the shelf and tailored solutions to Life Science companies. During this time, he has seen many changes to the industry including significant tightening of regulations and challenges of globalization. His primary objectives are to target the ongoing investment in research, development and quality effectively and to lead the company in-house research and development.