The new Medical Devices Regulation (MDR) requires medical device manufacturers to maintain specified records for a minimum of 10 years (non-implantable devices) after the clinical investigation (trial) has ended, or if the device is placed on the market, at least 10 years after the last device has been placed on the market. This seems simple enough until you try to apply the requirements.
The MDR also allows member states to apply penalties for non-compliance with the regulation, which should be “effective, proportionate, and dissuasive”.
In our webinar recording, guest host Stuart McCully, will explore the penalties, challenges and solutions associated with medical device clinical investigation records management.
Don’t miss the opportunity to stay informed and protect your business from the potential penalties of non-compliance.
Who’s It For?
Anyone working with or responsible for data and documentation relating to medical devices.
Fill out the form below to access the recording:
12 Apr, 2022
Q&A: What are the principles of Good Laboratory Practice (GLP) and how do they impact your organisation?
23 Mar, 2022
eBook: An eTMF Archiving and Preservation Guide – Revised for 2022
27 May, 2022