As of 2020 vigilance reporting includes Post Market Surveillance Reports (PMSR) for Class I devices and Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III, as well as Class C and D IVD devices. Similar to pharmaceuticals, this report will summarize PMS data and describe any preventive and corrective action taken during the reporting period in relation to the device(s).
Post Market Surveillance Report
Mandatory for low risk Class I devices. Summary of results and conclusions of PMS data along with a rationale and description of any preventive and corrective actions taken for a product on the market. The PMSR must be available on request and updated when necessary.
Perodic Safety Update Report
Extension of PMSR for higher risk devices (Class IIa, IIb, III, and medical devices for in vitro diagnostics (IVD) Class C and D). In addition to data included in the PMSR, a summary of post market information, vigilance report, and current status of the devices on the European market is integrated. The PMSR must be updated regularly and reviewed by the authorities.
In order to comply with the latest EU medical device regulation, manufacturers are required to provide PSURs and PMSRs for each product. At IASON consulting we are always up to date with the requirements of the regulatory authorities. This is why we are committed to providing the best services in the medical device sector.
Regularly updating PMSRs and PSURs can be time consuming and tie up human resources. In order for you to focus on your daily business, we at IASON consulting are able to take care of the complete PMS reporting process.
According to the MDR 2017/745, PSURs for Class IIb (implantable), Class III and IVD Class D devices are submitted to EUDAMED electronic system for review of the competent authority. Although EUDAMED will not be completely ready for usage in 2020, submission to an electronic system will be mandatory.
No two projects are the same. Therefore, at IASON consulting we work in tandem with you, providing comprehensive scientific and regulatory guidance, where needed. The past has shown that this level of cooperation leads to the highest possible acceptance rate at the regulatory authorities.
Prevent obsolete compliance / administrative work. We make sure that your PMS documentation contains exactly the reports it needs for your specific product. In contrast to policies for drug PMS, requirements for medical devices differ. This is why we believe in a pragmatic PMS-approach specifically designed and tailored for medical devices.
According to MDR Article 83 / 84 (Section 1.1. of Annex III) a Post Market Surveillance Plan shall be prepared for medical devices (except custom-made devices). The legal manufacturer must collect and utilize all available information and then address it in a PMS-plan. Capitalize on our experience in drug PMS combined with vast knowledge on medical device documentation. Our consultants will be happy to assist you during the process of drafting a precise PMS-plan.