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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.

Categories: News

New Vigilance documents published on the European Commission website!

The following important vigilance documents have been published on the European website:

The new Manufacturer’s Incident Report (MIR) Form has been updated and a copy of the latest version (version 7.2) and detailed guidance/ help text that may assist in completing the form are available on the Commission website.

Based on the additional guidance on the MEDDEV 2.12/1 rev.8  section 4, the current version of the MIR Form included a number of new concepts:

  • The information is presented in a new structure.
  • Introduces international IMDRF coding/ terminology.
  • Introduces a definition of similar incidents and requires similar incidents trend data in a tabular format.
  • In preparation for the future EU MDR it also introduces (not mandatory yet):
    • the concept of SRN which will be utilized greatly in the future under the new regulations.
    • the use of UDI.

The updated version of the MIR Form V 7.2 will become mandatory from January 2020.

However, if you are a manufacturer and have already adapted your IT system to version 7.1, you may use this version until the end of March 2020.

For more detailed information, please do not hesitate to contact your MDSS team!

Categories: News
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