Annex III EU MDR
EU MDR Annex III
The Annex III of Medical Devices Regulation [MDR] (EU) 2017/745 highlights the aspects related to Post Market Surveillance of a medical device.
As a Medical Device Manufacturer, you should keep the following points in mind –
- Developing a post-market surveillance plan that includes:
- Collecting and utilising available information
- Addressing serious and non-serious incidents and undesirable side effects
- Using relevant specialist or technical literature, databases and/or registers
- Incorporating feedback and complaints from users, distributors, and importers
- Covering a proactive and systematic process to collect information
- Employing effective and appropriate methods and processes to assess collected data
- Using suitable indicators and threshold values to continuously reassess benefit-risk analysis and risk management
- Employing effective and appropriate methods and tools to investigate complaints and analyse market-related experience
- Establishing methods and protocols to manage trend reports and communicate with authorities and users
- Fulfilling the manufacturer's obligations laid down in Articles 83, 84, and 86
- Identifying and initiating appropriate measures including corrective actions
- Using effective tools to trace and identify devices for which corrective actions might be necessary
- Developing a PMCF plan or a justification for why a PMCF is not applicable.
- Preparing a PSUR and post-market surveillance report.
- Once a Medical Device is placed on the market, the legal manufacturers have a legal requirement to follow post-market surveillance requirements. This includes performing regular risk analysis, establishing protocol to manage trend reports and communicating with the authorities and the users along with monitoring and reporting adverse events/incidents.
In addition to PMS requirements, EU MDR introduced the need for appointing a Person Responsible for Regulatory Requirements – PRRC. Click here to know more about a PRRC.
Pre Market or Post Market – our experts are right here to support you with a FREE 30 minute consultation and defining the right step towards compliance!
Drop us an email – mdd@mddltd.com or fill out an interest form - https://mailchi.mp/8e91e0f1dba0/c3prlu9zgy
We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!
