There has been an update to the guidance document MDCG 2023-3. Originally published last year, this document provides clarification on key terms and concepts outlined in Section 2, Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Its purpose is to establish a shared understanding of these terms and concepts, ensuring the effective and harmonized implementation of the vigilance requirements under these Regulations. The document is intended for competent authorities, economic operators, and other relevant stakeholders. Some definitions included here are adapted from the Guidelines on a Medical Devices Vigilance System, updated as necessary to align with the MDR and IVDR.
A summary of the changes can be found below:
- Structural Updates:
- Renumbering of general questions from Q.3 onwards due to the addition of new questions.
- Insertion of the term “Regulations” and IVDR article references where applicable.
- Adjustments made to align the document with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
- Addition of a table of contents for improved document navigation.
- Introduction:
- New sentences added clarifying the interpretation of legal text and references to MDR and IVDR.
- Footnote 1 updated to reference Directive 98/79/EC and indicate obsolescence under the Regulations.
- Content Updates for Specific Questions:
- Question 1
- Added a new table outlining definitions of an incident and a serious incident; paragraphs amended for consistency
- Footnote 4 expanded with IVDR-related details.
- Flowchart has Updated to include IVDR-related terms and a new explanatory sentence.
- Minor rephrasing of Reportability under MDR for clarity.
- Question 2
- Added IVD-specific examples; removed text related to psychological trauma; revised order in a sub-bullet; new examples of serious public health threats.
- Question 3
- Added a new IVD-related sentence and examples.
- Question 4 – 5
- Minor amendments and additions related to device use and manufacturer information requirements.
- Question 6
- Expanded explanations on use-errors and other contributory factors.
- Question 7-21
- Introduction of new questions and revisions, including:
- Questions on indirect harm related to IVDs, expected erroneous results, reporting CE-marked devices in studies, preventive/corrective actions, and regulatory implementations.
- Newly added or modified footnotes throughout the text for detailed references and clarifications.
- Introduction of new questions and revisions, including:
Overall, the revisions enhance clarity, better align with IVDR regulations, and introduce more examples and detailed references to support compliance and interpretation.
The updated guidance document can be accessed using the following link
