Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF)

Post-Market Surveillance

Post-market surveillance (PMS) under the European Union Medical Device Regulation (EU MDR) refers to the ongoing process of monitoring the safety and performance of medical devices after they have been placed on the market.

According to EU MDR requirements, manufacturers are responsible for conducting post-market surveillance activities to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout the entire device lifetime.

The manufacturer should address the collection and utilization of relevant sources including

Serious incidents, PSURs, and field safety corrective actions
Non-serious incidents and undesirable side-effects
Information from trend reporting
Specialist or technical literature, databases and/or registers
Feedback and complaints
Publicly available information about similar medical devices

Manufacturers shall collect and analyze the data, including feedback from patients, healthcare professionals, and clinical investigations, to identify any potential safety issues or performance problems.

Additionally, based on the Article 83(3) of EU MDR, the gathered data should be used:

To update the benefit-risk determination and to improve the risk management.
To update the design and manufacturing information, the instructions for use and the labelling.
To update the clinical evaluation, and the summary of safety and clinical performance, and to the identification of needs for preventive, corrective or field safety corrective action.
For the identification of options to improve the usability, performance and safety of the device.
To contribute to the PMS of other devices (if applicable).
To detect and report trends.

Manufacturers must update their risk management system based on the information collected during post-market surveillance activities.

If any safety issues or performance problems are identified during post-market surveillance activities, manufacturers must implement appropriate corrective and preventive actions to address the issue and prevent it from happening again.

Manufacturers must report any serious incidents or safety issues to the relevant regulatory authorities, including the European

Database on Medical Devices (EUDAMED).

The PMS activities should be conducted according to a documented PMS plan per Annex III 1.1 of EU MDR. The extent of PMS activities depends on several factors, such as the existing or new risks associated with the medical device, the chosen data sources or the expected quality of the available information on safety and performance

Depending on the device risk classification, the system also must describe the relevant report output either being the PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.

Our PMS Service

Process and Templates Development

Gap Assessment

Implementation

Continuous update of documentation

Post-Market Clinical Follow-up

Post-Market Clinical Follow-up (PMCF) is a key component of the EU MDR that requires manufacturers to collect clinical evidence about their medical devices after they have been placed on the market.

PMCF is a continuous process that involves the collection, analysis, and evaluation of clinical data about the device which bears the CE marking and is placed on the market or put into service within its intended purpose. This data is used to confirm the safety and performance of the device in real-world conditions and to identify any potential issues or risks associated with the device that may not have been identified during the pre-market clinical evaluation. PMCF is a continuous process that updates the clinical evaluation and should be addressed in the post-market surveillance plan and conduced according to the PMCF plan per Annex XIV Part B of EU MDR.

The PMCF plan should be based on the specific characteristics of the device and its intended use, and should be designed to address any uncertainties or gaps in the clinical evidence that were identified during the pre-market clinical evaluation.

The key steps involved in PMCF under the EU MDR include:

Developing a PMCF plan: The PMCF plan should describe the methods and procedures for collecting, analyzing, and evaluating clinical data about the device, as well as the specific objectives of the PMCF study.
Conducting the PMCF study: The PMCF study involves collecting clinical data from a range of sources, including post-market surveillance data, clinical investigations, and literature reviews.
Evaluating the PMCF data: The PMCF data should be analyzed and evaluated to identify any potential issues or risks associated with the device and to verify its safety and performance.
Updating the clinical evaluation report: The PMCF data should be used to update the clinical evaluation report for the device, which is used to demonstrate compliance with the EU MDR requirements

PMCF is a critical component of the EU MDR that helps to ensure the ongoing safety and effectiveness of medical devices in real-world conditions. It is an important aspect of EU MDR compliance and manufacturers must have a robust PMCF plan in place for their devices.

Key points:

Under EU MDR, PMS and PMCF plans will undergo a high level of scrutiny according to Article 83, Annex III and Annex XIV of EU MDR respectively.
PMCF activities should be planned according to the needs of the subject device and include specific and general activities where appropriate.
It is important to ensure aims of PMCF in accordance with Annex XIV Part B of EU MDR are specifically fulfilled by the planned PMCF activities.
PMCF activities should be appropriate considering the expected device lifetime

Our PMCF Service

Process and Templates Development

Gap Assessment

Implementation

Continuous update of documentation