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Know the essential EU MDR requirements.
The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules.
The time to plan and act on these changes is now.
Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more will be affected. Plus new requirements are coming into play, including Eudamed and periodic safety update reports (PSURs).
This webinar will describe what to do now, what to keep your eye on, and real-world examples that show how industry is working through the changes. Interpretations will evolve, but our experts will be able to help you navigate the process.
What's covered?
In addition to the background/history of EU MDR, the stacking effect for notified bodies, and R&Q's proposed solution, the session will cover the key EU MDR changes, including:
- Classification changes
- Increased clinical evidence
- Expert group consultations for higher risk devices
- Increased scrutiny of technical documentation
- Supply chain controls
- Emphasis on control of reprocessing and reuse of devices
- “Responsible Person”
- Common specifications
- Trending and PMS
- State of the art assessments
- Eudamed database
- Unique Device Identification (UDI)
- General safety and performance requirements
- Unannounced audits
- What to do: R&Q recommended next steps
Key takeaways
- Learn the essential EU MDR requirements
- Know how it might impact my company
- Understand immediate actions and potential next steps
- Practical tips and guidance for implementation
- Valuable insight from experienced industry leaders
Who should view?
This session is designed for medical device manufacturers who market in the EU.
Also, newly appointed medical device companies in areas of cosmetics, cosmetic lights/lasers, colored contact lenses, cleaning and disinfecting solutions, sub-dermal and trans-dermal implants are a good fit for this session.
Job functions include:
- C-Level Executives
- RA/QA Directors
- Quality Managers
- Regulatory Affairs Managers
- Regulatory Specialists
- Quality Specialists
- Quality Engineers
