Thousands of MedTech companies are scrambling to update their technical files for compliance with the MDR because their CE Certificates are expiring in 2024, and they need to submit an updated technical file to their Notified Body in 2023. The most significant difference between MDD technical file requirements and the MDR technical file requirements is the addition of Annex III, Technical Documentation on Post-Market Surveillance. The essence of Post-Market Surveillance (PMS) is not complaint handling and customer satisfaction. The intent behind creating a PMS plan and collecting PMS data has four critical elements:

1. proactively identifying potential problems with your device
2. verifying that risk controls not fully verified before commercialization are effective
3. evaluation of your device against the state-of-the-art
4. providing inputs to your new product development process

To accomplish the above goals, you must understand how your risk management file is the foundation for each element. You also need to improve your database search skills.

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