Key Terms in the Medical Device Regulation

Medical Device Regulation

Key Terms and Concepts in the Medical Device Regulation – Vigilance

The vigilance requirements under the EU’s medical device regulations can be complex and confusing. To help you navigate this landscape, the Medical Device Coordination Group (MDCG) has released a guide to key terms and concepts in Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR).

This guide is a valuable resource for anyone involved in the medical device industry, including competent authorities and economic operators. It establishes a common understanding of important definitions and concepts necessary for effective implementation of vigilance requirements.

The guide includes definitions from the Guidelines on a Medical Devices Vigilance System, modified where necessary for alignment with the MDR. It covers medical devices, accessories for medical devices, and products listed in Annex XVI to the MDR.

While the guide is non-exhaustive, it should be read in conjunction with the MDR, relevant standards, and other MDCG guidance documents. Note that terms and concepts outlined in the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are outside the scope of this guide.

In conclusion, our guide to key terms and concepts in the MDR is a must-read for anyone looking to understand the vigilance requirements under the EU’s MDRs. Access this valuable resource to gain a clear understanding of these requirements and ensure effective implementation.




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