Impact of New Medical Device Regulation on Records Managers

Regulations / 26 Jan, 2023

Webinar Recording: The Impact of the New Medical Device Regulation on Records Managers

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:

Caitlin Morris

Caitlin is the Content Marketing Manager at Arkivum. She joined the company in 2022 and is responsible for internal and external content creation and management. Caitlin has over 4 years of business and marketing experience.

To receive our latest news and blogs straight to your inbox, please enter your email address.

Follow us on