Does Your Organization’s Post-Market Clinical Follow-Up (PMCF) Plan Adequately Reflect the Intensity Required in the Clinical Evaluation Report (CER) Under the Newest Medical Device Regulations?
Author: Suzanne Broussard
Post-market clinical follow-up (PMCF) requirements have increased under the newest Medical Device Regulations (MDR) 2017/745. All medical devices will be required to meet these standards, and the deadline is here. The possible 1-year extension for the application of MDR might give manufacturers a little wiggle room to achieve compliance, but not much.
The European Commission (EC) states in a nutshell that one of the reasons for the new regulations is to strengthen post-market surveillance requirements for manufacturers.
The goals for these new regulations are to:
Improve the quality, safety, and reliability of medical devices
Strengthen transparency of information for consumers
Enhance vigilance and market surveillance
The EC considers these newest regulations as providing extremely important improvements to modernize the current system and, therefore, medical device manufacturers need to make every effort to be compliant or risk further delays in obtaining a CE marking for their device.
The PMCF plan must establish processes that proactively and systematically collect information from a variety of sources. These sources include serious incidents, Periodic Safety Update Reports (PSUR), field safety corrective actions, inputs on non-serious injury, undesirable side-effects, trend reports, literature, databases, registers, feedback and complaint sources form users, distributers and importers, as well as publicly available information on similar medical devices (MDR 2017/745, Annex III).
The PMCF plan should document the method in which the PMCF should be performed. Therefore, the PMCF plan needs to specify the methods and procedures that will be used by the manufacturer to proactively collect the clinical data and the data’s subsequent evaluation. The plan’s aims are to:
Confirm the safety and performance of the device throughout its expected lifetime,
Identify previously unknown side-effects and monitoring the identified side-effects and contraindications,
Identifying and analyze emergent risks on the basis of factual evidence,
Ensure the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
Identify possible systematic misuse or off-label use of the device with a view to verify that the intended purpose is correct.
Choosing the post-market data to be collected in the PMCF plan is not an easy or straightforward task. The plan must include pertinent parameters to ensure the device is safe and effective. However, including too many or irrelevant variables may result in low response rates and/or missing data. The manufacturer should also consider that some data will be visible to the public. Indeed, one of the goals of the new regulations is to introduce transparency into the system to keep the general public informed, allowing patients to be more engaged in making their healthcare decisions.
The PMCF plan plays a central role under MDR 2017/745 since it lays the groundwork for the PMCF studies that subsequently interface with PSUR, Summary of Safety and Clinical Performance (SSCP), risk management files, CER updates, labeling, and IFU.
The data acquired through the application of the PMCF plan can provide strong evidence as to the safety and efficacy of the device and details about the clinical risks associated with use. Analysis of these post-market clinical data in combination with clinical literature is a powerful tool for manufacturers to improve product performance and support claims to regulatory agencies.
Getting these done is very time consuming and requires significant expertise, especially since the PMCF plan is an integral part of the quality system under MDR. The level of specificity necessary for the methods and protocols is intense.
The PMCF Plan must, at the very least, include the following:
(a) The general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
(b) The specific methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained feedback from users, screening of scientific literature and of other sources of clinical data;
(c) The specific methods and procedures of PMCF to be applied such as evaluation of suitable registers or PMCF studies;
(d) A rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
(e) A reference to the relevant parts of the clinical evaluation report referred to in section 4 and to the risk management referred to in Section 3 of Annex I;
(f) The specific objectives to be addressed by the PMCF
(g) An evaluation of the clinical data relating to equivalent or similar devices;
(h) Reference to any relevant CS, harmonized standards when used by the manufacturer, and relevant guidance on PMCF; and
(i) A detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.
At Criterion Edge, we understand how important the PMCF plan is to the success of your device’s new or annual CER and, thus, ultimately compliance with regulatory authorities and marketing in the European Union. Our experienced medical writers can provide guidance and expertise on the PMCF plan or any other aspect of your CER. If your organization needs expertise or just some breathing space for your medical writers, please reach out to us to chat.