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 medical device regulations. Access this valuable resource to gain a clear understanding of these requirements and ensure effective implementation.
Download the document here: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices .
For more news and updates from the medical device industry, be sure to check out MDSS News & Views.
Add Comment
This policy contains information about your privacy. By posting, you are declaring that you understand this policy:
- Your name, rating, website address, town, country, state and comment will be publicly displayed if entered.
- Aside from the data entered into these form fields, other stored data about your comment will include:
- Your IP address (not displayed)
- The time/date of your submission (displayed)
- Your email address will not be shared. It is collected for only two reasons:
- Administrative purposes, should a need to contact you arise.
- To inform you of new comments, should you subscribe to receive notifications.
- A cookie may be set on your computer. This is used to remember your inputs. It will expire by itself.
This policy is subject to change at any time and without notice.
These terms and conditions contain rules about posting comments. By submitting a comment, you are declaring that you agree with these rules:
- Although the administrator will attempt to moderate comments, it is impossible for every comment to have been moderated at any given time.
- You acknowledge that all comments express the views and opinions of the original author and not those of the administrator.
- You agree not to post any material which is knowingly false, obscene, hateful, threatening, harassing or invasive of a person's privacy.
- The administrator has the right to edit, move or remove any comment for any reason and without notice.
Failure to comply with these rules may result in being banned from further commenting.
These terms and conditions are subject to change at any time and without notice.
UK Responsible Person6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK
+44 7898 375115
Comments