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Post-Market surveillance, personalized medical devices and Cybersecurity - IMDRF guidance documents April 2023
2023-04-27 20:43

The IMDRF was properly established in 2011 and have members from around the world. Representatives for, the medical device authorities of Australia, Brazil, Canada, China, Japan, the European Union, Russia, Singapore, South Korea, the United Kingdom and the USA are part of the forum.

Professionals on this forum provide guidance on strategies, policies, directions, membership, and other activities. During April 2023, the group has issued several guidance. We support you summarizing them, however, further information can be found on the IMDRF official website (https://www.imdrf.org/)

1. Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form.

The guideline is designed to be used as a communication system that involve confidential information for serious public health issues. It provides guidance on the information exchange infrastructure to be developed and established between IMDRF members.


2. Personalized Medical Devices: Production verification and Validation.

The document is intended to be read together with the N49 and N58. It is intended to be used by all the stakeholders in the personalized medical device supply chain. The guideline is divided in two parts, first of them contains information on verification and validation of specified design envelope for patient-matched medical devices. Second part refer to considerations for verification and validation of the medical device production system (MDPS).


3. Principles and Practices for the Cybersecurity of Legacy Medical Devices –

The guidance aims to support stakeholders in the identification of legacy devices and realistic approaches to preserve the cybersecurity of legacy medical devices. It provides a variety of options for the stakeholders to implement measures in different health systems considering local regulations, it is also recommended to read this guideline together with the IMDRF N60 “Principles and Practices for Medical Device Cybersecurity”.


IMDRF guidance have been long recognized as regulatory best practices, for that reason knowing and understanding them is an essential task for any company in the industry.

Having so much information can be overwhelming and knowing if it applies to your products or processes even more. Therefore if you are interested in Regulatory advice or taking your products to any of the IMDRF member markets, Osmunda can support you.

Contact us, we will be glad to help!


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