Postmarket Surveillance Under EU-MDR: Preparing for New Requirements
The new EU-MDR is scheduled to take effect in May 2021.
What reports are required for your postmarket surveillance (PMS) system? When do you need to prepare a postmarket clinical follow-up (PMCF) What should you include in your PMCF plan? How do you link PMS data, PMCF data and risk management?
You need to fully understand the EU-MDR’s PMS requirements and how they interconnect.
Postmarket Surveillance Under EU-MDR: Preparing for New Requirements maps out the requirements that are spread out among various articles and annexes of the mammoth regulation. Don’t miss a step in building your PMS plan:
- Understand the requirements for periodic safety update reports
- Create a summary of safety and clinical performance
- Identify and report serious incidents
- Determine if field safety corrective action is needed
- Transmit safety reports while the EUDAMED database is being updated (projected to finish in 2022).
The report also includes valuable tools. You’ll receive a template for reporting serious incidents, guidance on preparing summaries of safety and clinical performance and a multi-part Excel spreadsheet to help you apply all the EU-MDR postmarket safety requirements.
Ensure you’ll stay current with the EU’s new PMS requirements. Order your copy today.
Who Will Benefit
- Quality management staff
- Regulatory compliance staff
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