The post market clinical follow up is collective clinical experience data relating to the device after it is available in the market. The details of data include its analysis, device registration, ad performing a new investigation on the device. It is the responsibility of the higher authority. Every manufacturing team should adhere to the latest rules and regulations to ensure that they deliver top-notch medical devices in the market.
The post market follow up is important, and the manufacturing tea should include analysis of the device in the post market plan. This is what the EU MDR asks the manufacturing team to comply with.
Why is Clinical Follow-up Part of Post Market Surveillance Strategy?
In the post market clinical follow up, the surveillance strategy helps as the data collected during the pre-market phase may miss on some vital events. The strategy for the post-market period is important as it helps identify the new risks in running the medical device. It should adhere to the latest safety measures when it is available in the market.
What are the Steps Included to Plan the Follow-up?
Whichever source you approach to set up a post-market plan, it is better to start with the PMCF strategy. It should be such that it helps in completing the essential steps to check the quality of the device.
Following this, it is about setting up the device that includes an investigation of the device. After this, the manufacturing team should update the reports as per the clinical data in the post-market period. This is crucial as it would determine the need to modify the device or make any necessary changes.
What Update the Clinical Evaluation Report of Medical Devices?
The result of PMCF will include complaints and vigilance, and it is the responsibility of the manufacturing team to analyze it. For any quality issues, the manufacturers should evaluate the issues and update the clinical report accordingly. Depending on the current report, it will be easy to understand the condition of the medical device. It would help one know about the risks and benefits of using the device.
What is the Need for Follow-up under PMCF requirement as per EU MDR?
As per the new regulation, the manufacturers should prepare the report only after thorough research about the elements. It should include data on performance and the probability of risks in the device. It should also talk about the durability of the item and for any problems, the manufacturing team is responsible for resolving the issue at the earliest.
While going for a systematic approach, it should include correct evaluation only after a suitable demonstration. This would help understand its level of performance and how much improvement it requires.
How can the New Regulations help in Follow-up Process?
The new guidelines demand a strategic plan to ensure high quality a correct functioning of the medical device. It is the responsibility of the manufacturing team to ensure its quality ad delivers the best to the consumers. The follow-up report ensures that there is no probable chance of risk for the medical industry when using the device.