MDCG publishes Guidance on the Surveillance of Medical Devices and IVDs

At the end of 2025, the Medical Device Coordination Group (MDCG) published the guideline 'MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices'. What does it contain?

With the change from the Medical Devices Directive (MDD) to the Medical Devices/IVD Regulation (MDR/IVDR), the importance of post-market surveillance (PMS) of medical devices has also increased. This topic is covered in the 23-page guideline, which is divided into

Table of Contents
1 Introduction
2 Scope and Objectives
3 The PMS System Required by the MDR/IVDR
3.1 General Obligations
3.2 Specific Obligations for Manufacturers of Custom-Made Devices under the MDR
4 The PMS plan
5 The most important activities of the PMS system
5.1 Identifying suitable sources of available information for the
5.2 Collecting the necessary data
5.3 Evaluating and analysing the data
5.4 Drawing conclusions and determining the need for action
6 The interactions of the PMS system with other important aspects of the QMS 
7 References
Appendix 1 Overview of PMS obligations in the MDR and IVDR
Appendix 2 IVD and medical device scenarios: Use of PMS data to update other processes

Chapter 2 provides a relatively concise description of the objectives of the guideline. The main objectives are as follows:

1. Description of the PMS system
2. Description of the PMS plan
3. Description of the most important activities within the PMS system
4. Clarification of the interactions of the PMS system in accordance with Article 83 MDR/Article 78 IVDR with other important aspects of the QMS, as described in Article 10(9) MDR and Article 10(8) IVDR

However, it also addresses what does not fall within the scope of the guidelines. These are

• no details on how a manufacturer should prepare a Periodic Safety Update Report (PSUR) or a post-market surveillance report. (For this, explicit reference is made to the guidelines on PSUR in MDCG 2022-21),
• No description of the requirements for exemption of health institutions in accordance with Article 5(5) MDR/IVDR (in-house products),

The introduction highlights the relevance of a PMS within a quality management system. The scope of the PMS should be proportional to the risk of the product. The tasks of a manufacturer after placing a product on the market are clearly addressed:

• systematically and actively collect information from experience with their products
• use this information to update their technical documentation
• cooperate with the national authorities responsible for vigilance and market surveillance

The data and findings from PMS activities must then be used to

• update relevant parts of the technical documentation (e.g. the risk assessment and clinical evaluation) and is therefore also part of the technical documentation
• determine the need for preventive and/or corrective measures
• achieve greater transparency

Assistance in implementing the above requirements is provided in the guideline in the form of three tables, which provide overviews (Tables 1 and 2) as well as direct assistance in connection with the quality management system (Table 3).

• Table 1 Summary of the elements that must be included in the PMS plan in accordance with Annex III Section 1(b) MDR/IVD
• Table 2 Breakdown of Annex III Section 1(a) MDR/IVDR: Information to be recorded and use of this information
• Table 3 Interactions of the PMS system with other important aspects of the QMS

The guideline concludes with two annexes:

• Annex 1 - providing an overview of the PMS requirements in the MDR and IVDR, and
• Annex 2 - presenting scenarios for how PMS data can be used to update other processes (with illustrative flowcharts).

Conclusion: Although it is explicitly stated at the beginning that the document cannot be regarded as the official position of the European Commission and that its contents are therefore not legally binding, the document naturally has a high status as 'state of the art'. It also provides useful information on the subject of post-market surveillance. 

You can find the complete guidelines on the EU website.