The MDR (Medical Device Regulation), including the Periodic Safety Update Report (PSUR) required therein, is the topic in the European medical technology industry. From May 2020, the PSUR will be mandatory for medical devices from class IIa. With almost the same name, yet different in content and objectives, India has defined its own MDR (Medical Device Rule) and thus also its PSUR.
SIMILARITIES AND DIFFERENCES
Which products are affected?
While the MDR requires a PSUR at varying intervals for all Class IIa, IIb and III medical devices, India defines the “Investigational Medical Device” for which a PSUR is required. This includes all devices that cannot demonstrate a “Predicate Device” or fall under certain requirements of the regulations.
How often does a PSUR need to be established?
The European MDR requires the PSUR throughout the lifecycle of the medical device and even defines it as part of the technical documentation. For Class IIa devices, the report must be updated as needed, but at least every two years. For Class IIb and III devices, it must be updated and submitted annually. For Class III and implantable devices, the reports are even reviewed by the notified body. In all other cases, the report is only required to be submitted.
The Indian PSUR only needs to be submitted in a limited period of time after the medical device is approved. During the first two years, every six months, and thereafter for two more years at annual intervals. It should be noted that if the market launch is still somewhat delayed after approval, the time requirements are always based on the time of the market launch and are postponed accordingly.
What needs to be taken into account?
The European PSUR requires the contents of the post-market surveillance plan according to Article 84 (described in Annex III, Section 1.1) as well as further contents according to Article 85. An update of the data is always required, i.e. a long-term view since product launch. The Indian specifications go one step further, they specify an exact content specification. And in contrast to Europe, they explicitly want “interval data,” i.e., an evaluation of the data for the respective period.
Speaking of which, the Indian PSUR must be submitted no later than 30 days after the end of the respective period.
What are the similarities and differences in content?
Indeed, the two reports have significant overlaps in content, e.g., in risk management, in the conclusions from the risk-benefit assessment, in the estimate on the number of users and their exposure to the device, and in the requirement for the indication for preventive and corrective actions performed. Nevertheless, the EU and India also set different priorities.
In the European specifications on the plan, many requirements relate to methods and process of analytics – reporting of trends is important. In contrast, India explicitly requires information on approval status in other countries, relevant new information, changes to product information to optimize use, and an update on clinical trials in India as well as globally. It is also interesting to note that India requests a separate chapter for individual case histories.
Different goals
In summary, the two PSURs have different objectives: While the European report is designed to cover the life cycle of higher-risk class medical devices, India wants to keep a close eye on innovative new devices, especially in the first four years, and get detailed information about the situation in the field.
As a reminder, Class I devices under the European MDR are not required to have a PSUR, but rather a post-market surveillance report, which does not have to be submitted on a regular basis. However, it should also be based on a post-market surveillance plan according to Article 84 and Annex III, Section 1.1, which makes it as detailed as a PSUR in terms of topics and scope. The difference here is the depth with which data must be collected and analyzed.
After this short excursion to India, we would like to turn to the European PSUR in detail, because here, too, there are enough abbreviations to cause confusion. Read the second part.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
