The MDCG has recently published a guidance concerning post-market surveillance requirements for Medical Device and IVD’s. Unless otherwise specified, this guidance applies to all medical devices (MDs) and in vitro diagnostic medical devices (IVDs). To offer some background to this guidance document, Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish a regulatory framework to ensure a high level of protection of health and safety for patients, users and other individuals, while supporting innovation. Devices may only be placed on the Union market if they comply with the requirements of these Regulations.
To ensure continued compliance and to systematically take into account real-world experience gained from device use, manufacturers are required to implement and maintain a Quality Management System (QMS) that includes a post-market surveillance (PMS) system. In accordance with Article 83 MDR and Article 78 IVDR, and as reinforced by Recitals 74 MDR and 75 IVDR, PMS is a structured and proactive process that forms an integral part of the manufacturer’s QMS and must be proportionate to the risk and nature of the device.
PMS is a continuous activity carried out throughout the entire lifetime of a device, enabling manufacturers to monitor safety, quality and performance, update technical documentation, identify the need for preventive or corrective actions, and cooperate with competent authorities.
The objectives of this guidance are to:
- Describe the post-market surveillance (PMS) system.
- Describe the PMS plan.
- Outline the main activities carried out within the PMS system.
- Clarify how the PMS system, as required under Article 83 of the MDR and Article 78 of the IVDR, interacts with other key elements of the quality management system (QMS), as described in Article 10(9) MDR and Article 10(8) IVDR.
This guidance does not cover the following:
- Detailed instructions on the preparation of a Periodic Safety Update Report (PSUR) or a post-market surveillance report. Specific guidance on PSURs is provided in MDCG 2022-21. While MDCG 2022-21 does not specifically address post-market surveillance reports, it may offer useful recommendations on the presentation of information in such reports.
- Requirements related to the health institution exemption under Article 5(5) MDR/IVDR (in-house devices). Nevertheless, health institutions are expected to review experience gained from the use of in-house devices and to implement any necessary corrective actions.
The guidance can be accessed using the following link
