Newsletter No 43 March 2024

Subject: Post-market clinical follow-up in the context of MDR

One of the biggest changes of the Medical Device Regulation (MDR) compared to the former Medical Device Directive (MDD) is the reinforcement of the requirements for clinical evaluation and post-market surveillance to medical device manufacturers. In connection with both processes, there is the post-market clinical follow-up (PMCF).

In this newsletter we will have a look at the PMCF, described in article 61 and part B of annex XIV MDR as a continuous process that updates the clinical evaluation and is addressed in the manufacturer’s post-market surveillance plan.

Which is the aim of the PMCF?

It is a proactive process to:

  • confirm the safety and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime.
  • identify previously unknown side-effects and monitor the identified side-effects and contraindications.
  • identify and analyze emergent risks on the basis of factual evidence.
  • ensure the continued acceptability of the benefit-risk ratio, referred to in Section 1 and 9 of Annex I in the MDR.
  • identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

How is the PMCF process managed?

The PMCF starts with the PMCF determination checklist, to identify the data required according to the aim above and to record the justifications in relation to no data required on certain aspects or even non-performance of PMCF, if applicable.

If the PMCF is applicable to a device family, the next step is to prepare a PMCF plan, to define the activities and methods to obtain the data, and the timelines for each activity. Examples of different activities related to PMCF are PMCF studies to confirm the safety and performance of the device, surveys to collect information about the use of a medical device, etc.

The findings of the PMCF are then analyzed by the manufacturer and documented in a PMCF evaluation report, that contains the following information:

  • Results of the activities related to PMCF, including all collected data, eventual justifications from the plan and justifications, analysis of the results and potential impact.
  • Evaluation of clinical data relating to equivalent or similar devices, including all data collected, analysis and conclusions, and whether changes of the state of the art, or newly identified hazards would have an impact on the devices benefit-risk determination, the clinical evaluation and/or the PMCF plan.
  • Impact of the results coming from each PMCF activity and from equivalent and/or similar devices on the technical documentation. At least, the clinical evaluation report and risk management file are considered.
  • Reference to any common specification(s), harmonized standard(s) or guidance document(s) applied, to conclude whether the collected clinical data still confirm adherence to these standards.
  • Overall conclusion of the findings, to be considered in the following clinical evaluation and risk management, and to highlight if any need for preventive and/or corrective measures has been identified.

The PMCF file is part of the Clinical Evaluation and the MDR Technical Documentation. This process is in scope of monitoring by the Notified Body.

Which is the role of the distributors?

While PMCF is the responsibility of the manufacturer, distributors play a key role in providing valuable information, mainly through PMCF surveys provided by the device manufacturer. The more PMCF data obtained, the more accurate the analysis will be, which will ultimately have a positive impact on patient safety.

 

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”. 

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supplies to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.

The next MDR newsletter will be issued in April. We take this March release opportunity to wish everyone a warm, happy, and wonderful Easter time.

Augusto Orsini
CEO STS Medical Group

Meritxell Laguna
Group Manager Regulatory Affairs
STS Medical Group