We have a IIa product that in the process of obtaining CE certificate, the NB required and PMCF plan states that we need to make a PMCF survey to collect post-market data to prove the safety and effectiveness. The survey is for user and physician who may use the device for treatment. Because we are not an EU country, we plan to finish the survey through the Online link.
The problem is:
1. The survey is included some patient data like the state of illness, evaluate whether the illness has improved, etc. But there is no patient name, address or other information included but device used frequency and some parameters. I don't know whether it is necessary to submit an apply to EC. For compliance, I have written an informed consent. Maybe this may follow the requirement of Article 74 in MDR 2017/745 that this will not produce additional invasive procedures or burdensome. So maybe we can exempt the EC. But there seems some countries require EC because the survey includes patient data. (I had asked the auditor about the EC requirement, but still unclear)
2. Seems there are too many requirements for data security in EU. I know if we want to exempt GDPR requirement, we can keep the survey completely anonymous, but this is difficult to achieve.
3. The time we begin to send the survey should be 1 or 6 months after we obtain CE certificate? We define in PMCF plan that the effect works after using the device for at least 1 month, and using for 6 months must be better.
I am completely confused by this survey.
The problem is:
1. The survey is included some patient data like the state of illness, evaluate whether the illness has improved, etc. But there is no patient name, address or other information included but device used frequency and some parameters. I don't know whether it is necessary to submit an apply to EC. For compliance, I have written an informed consent. Maybe this may follow the requirement of Article 74 in MDR 2017/745 that this will not produce additional invasive procedures or burdensome. So maybe we can exempt the EC. But there seems some countries require EC because the survey includes patient data. (I had asked the auditor about the EC requirement, but still unclear)
2. Seems there are too many requirements for data security in EU. I know if we want to exempt GDPR requirement, we can keep the survey completely anonymous, but this is difficult to achieve.
3. The time we begin to send the survey should be 1 or 6 months after we obtain CE certificate? We define in PMCF plan that the effect works after using the device for at least 1 month, and using for 6 months must be better.
I am completely confused by this survey.
