With the implementation of the new Medical Device Regulation (MDR) 2017/745 in the European Union, a lot has changed. Manufacturers are working to update their systems in order to meet the standards set in the new regulation. Reporting of post-market data and activities is one of the aspects that has changed. Depending on the class of medical device either a Post-market Surveillance Report, PMS Report, or a Periodic Safety Update Report, PSUR, is required. Figuring out which report is needed, when to submit the report, and what is required in the report can prove to be a challenge for manufacturers.
Devices classified as Class I need Post-Market Surveillance Reports according to EU MDR 2017/745.[1] These reports are fairly simple and only need to be updated as needed. The report should contain information on any Corrective and Preventive Actions (CAPAs) taken. Other than that, the EU does not require much in terms of a PMS Report. That being said, manufacturers of Class I devices should not be complacent about collecting post-market data, as that data will later be used for other types of reports and is also useful for remaining vigilant for any potential problems with the device.
For Class IIa, IIb, and III devices a Periodic Safety Update Report is required by the MDR.1 These reports require much more detail and need to be submitted on a regular basis. Class IIa devices need to be updated as needed or once every two years while Class IIb and III devices need to be updated annually at the very least.1 As stated before, the PSUR needs to be much more detailed than the PMS Report. The PSUR must contain the results of a risk-benefit assessment for example.1
Having a plan in place for post-market surveillance activities and reporting will greatly aid manufacturers in generating these reports. EMMA International can help develop these plans and design templates, procedures, and other tools needed for post-market activities. From start to finish and beyond EMMA International’s Full Circle Consulting can help companies place and keep products on the market. EMMA International’s team of consultants is available to help with any project, give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.
[1] Eur-Lex (April 2020) Regulation (EU) 2017/745 of the European Parliament and of the Council, Retrieved 11/18/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424
