The MDR (Medical Device Regulation) including the Periodic Safety Update Report (PSUR) required in it is the hot topic in the European medical device industry. As of May 2020 the PSUR will be mandatory for all medical devices of class IIa and higher. Using nearly the same name, but yet different in content and purpose, India has defined its own MDR (Medical Device Rule) and hence its own PSUR.
SIMILARITIES AND DISTINCTIONS
Which products are affected?
Whilst the MDR requires a PUSR for all class IIa, IIb and III medical devices at different intervals India has established a "Investigational Medical Device" which requires a PSUR. This affects all products not featuring a "Predicate Device" or underlying special requirements of the Rule.
How often does a PSUR have to be handed in?
The European MDR demands a PSUR through out the whole product life cycle and even makes it a part of the technical documentation. For Class IIa products the report must be updated when needed, however every two years at the latest. Reports on Class IIb and III devices must be updated and handed in annually. In case of Class III and implantable products the reports will even be reviewed by the notified body. In all other cases the report only must be presented.
The Indian PSUR only needs to be handed in for a limited period following the approval of the medical device. During the first two years every six month, thereafter for two more years on an annual basis. Attention should be paid to the fact that if the market launch is long in coming, the allotted period is always oriented towards the launch date and will be shifted accordingly.
What is to consider?
The European PSUR requests the items defined in the Post-Market-Surveillance Plan as per Article 84 (described in Annex III, section 1.1.) as well as additional items as per Article 85. In any case an update of all data is required, in the sense of a long-term study since introduction to the market. The Indian stipulations go one step further by providing an exact structure. And contrary to Europe it is "Intervall Data" that is demanded, meaning an analysis of the data gained during the respective time period..
Apropos: At the latest 30 days after the respective time period has passed, the Indian PSUR needs to be handed in.
Which similarities and distinctions are to be found in the content?
Actually the two reports share significant contentual aspects, e.g. on risk management, conclusions on Risk-Benefit-Evaluation, on estimating the number of users and their exposition to the device as well as the requirement to list any preventive and corrective action that was performed. Nonetheless the EU and India focus on different aspects in addition to those.
The European requirements for the plan give a lot of credit to analytic methods and processes - an important aspect is trend reporting. India on the contrary clearly demands information on the approval status in other countries, relevant new information, changes to the safety information based on improved usage. The fact that a seperate section on individual case histories is required in India, also catches one's attention.
To sum up, it can be said that both PSURs have a different purpose: Whilst the European report is aimed at the lifecycle of higher-class medical devices, India mainly focuses on innovative, new devices for the first four years and wants to be up to date on the situation in the field.
Keep in mind: Class I products as per the European MDR don't require a PSUR, but a Post-Market-Surveillance Report which needn't be handed in on a regular basis. However, it is also based on a Post-Market-Surveillance-Plan as per Article 84 and Annex III, section 1.1. Virtually this makes it cover the same items with the same extent as a PSUR. The difference can be made between the levels of detail of the data to be gathetered and evaluated.
Following this short trip to India, we would like to consecrate ourselves to the European PSUR in detail as there are also sufficient abbreviations for potentially causing confusion. Read the second Part.
Please note that the details and bullet points listed are not intended to be exhaustive, are supplied without liability and only serve as information.