Guide – MDCG endorsed documents and other guidance documents.

The majority of documents on this site need approval by the Medical Device Coordination Group (MDCG) as per Article 105 of the MDDR and Article 99 of IRD. The document should draft in coordination with interested parties. Each representing various group groups and being denominated according to the following format: MCC Year number. It presents the common understanding that the MDR should be applied in practice. Objected is efficient and harmonized execution of this measure. The presented document is not legally binding, and he is not intended to bind legally.

PMCF Guidance

An essential constituent of Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF), is a continuous lifecycle process; wherein updating device clinical evaluation, confirming its safety and clinical performance throughout its expected lifetime.

The increasing requirements under the MDR would necessitate prudent, thorough planning by manufacturers, preparing to certify or gain recertification under the new Regulation.

The MDCG Guidance document details the methods and procedures in a PMCF plan. Manufacturers can set up these plans to proactively collect and assess clinical data of a CE-marked medical device.

Manufacturers should document the findings from the PMCF is. The manufacturer should set up a PMCF evaluation report which is a part of the CER and technical document. The Notified Body will assess the adequacy of the PMCF plan basis, the manufacturer’s procedures, and documentation of the PMCF. As well as the justification for non-performance of PMCF.

Post-Market Clinical Follow-Up Overview

PMCF is an active collection of clinical experience with a product after its market announcement. These activities can range from the analysis of device information to the completion of new clinical trials. European and American regulations advise medical device manufacturers to consider PMCF as part of their post-market surveillance plans. How do you explain it? There are limitations on clinical data collected in the predistribution stage to predict rare events or incidents accurately. In addition, it’s important to monitor post-market clinical results to determine all new and unexpected potential risks.

MDCG Post-Market Clinical Follow-Up (PMCF)

The Medical Device Coordination Group has released a draft Plan for establishing clinical follow-up post-marketing that should be used on the European market. Due to the legal nature of the document, its provisions are unenforceable and should be considered recommendations to consider.

European Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices

Medical manufacturers must conduct post-marketing Clinical Following-up investigations to gather additional information about a product already approved for sale in Europe. The PMCF – Strategy outlined in the PMS – Plan is crucial that companies maintain compliance using MDR 2017/546 Medical Devices regulations. Sadly, many companies feel overwhelmed or confused. Emergo’s Clinical Team can assist in the planning of these medical study programs.

Regulatory background

The plan for the PMCF should contain proper information about the methods and procedures used by the manufacturers to collect and evaluate the clinical data deriving from a period of continuous usage.

The MDCG also identifies the following areas: The present PMCF template provides medical device manufacturers with the additional information beneficial for achieving and sustaining compliance.

It is also expected to simplify supervision carried by the notified bodies and National Regulatory Authority in post-market surveillance.

Objectives

Through the PMCF, the manufacturer is expected to ensure –

  • Continued acceptability of identified risks,
  • Identify previously unknown side-effects,
  • Most importantly, monitoring the identified side-effects and contraindications.

Based on actual evidence, the manufacturer should identify and analyze emerging risks and ensure that the benefit-risk ratio matches MDR guidelines. Further, the PMCF aims to validate that the device is deployed correctly for the product’s intended use. The PMCF must also identify cases of possible systematic misuse or off-label use of the device.

Key points to be covered

Manufacturers should describe the post-market activities that will conduct, including the procedures corresponding to the specific product, the aim, and the rationale for each action described as appropriate to achieve the required objectives.

Some commonly used PMCF methods would include –

  • Collecting data in registries,
  • Screening scientific literature and other clinical data sources,
  • post-market studies,
  • and patient and health care professional surveys.

At the outset, one must define the need for conducting a particular PMCF activity; With a note on where the market is coming from, such as a Notified Body, as a part of PMS, CER, Risk Management, etc.

Each activity should define the aim(s) and give the rationale for choosing different procedures/methods and justifications for study design, sample size, timelines, inclusion/exclusion criteria, and endpoints.

Single N case studies can be appropriate when the more useful double-blind, randomized studies do not exist.  In-depth literature research is required to justify the comparator, the basis of the intended purpose, and state of the art.

In addition, it should also list timelines for each of the activities mentioned above and the known limitations of the planned activities.

An important consideration here is that statistical justifications should be provided, as appropriate, for the expected outcomes, rationalizing why this is satisfactory in light of the residual risks.

The storage of PMCF data will generally be in clinical and regulatory databases, screening scientific literature and other sources, and analyzing post-administered patient health care. Intensive Literature Research is mandatory to justify the comparator, the basis of the intending effect, and state of the art.

PMCF study design and planning

The plan should describe the structure and methodology of the planned Study. Ethics Committee Approvals (ECS) are primarily necessary for PMCF studies through competence authority approval is generally not necessary. Approval processes are not consistent across EU countries. Therefore, manufacturers should consider these requirements country-by-country to ensure compliance. In cases where the manufacturer can use a CE marking device in clinical trials, the planned research assessment which may deviate from clinical practice may become a requirement. Any proposed off-label use of a CE marking product will trigger competence authority approval requirements.

PMCF studies:

Manufacturers should provide a summary of the planned studies in line with the requirements above.

For example, the PMCF study could contain details on extended follow-up of patients included in the pre-market clinical investigations, new clinical investigations within the intended use, as well as retrospective, historical studies.

Ethics Committees (ECs) approvals are necessary for PMCF studies. Any number of medical ethics and even general ethics texts are available.

Citing one and detailing general conformance with fundamental tenets may provide the reviewers with confidence in those preparing the PMCF.

Manufacturer device registry:

Depending on the type of medical device or the specific group the device belongs to; can provide such a registry can be provided with a description and a summary of the plan.

The device and accessories should specify the quality and quantity of data and should analyze specific protocols to be followed.

It can utilize appropriate national public registries with clinical data on the manufacturer’s device and utilize similar devices and should establish here.

Planned Real-world evidence (RWE) analyses:

The scope is to conduct investigations based on actual-world data based on the requirements above. The real-world data should be from reliable sources and of sufficient quality.

Often such evidence appears by reference or in summary form in sales literature and can shorten research times in locating relevant findings and their publication.

Also, the manufacturers could choose to include surveys planned by health care professionals and patients, which will gather information on the usage of the device under evaluation.

Assessing clinical data about equivalent or similar devices

Here, the literature search again plays a significant role. Clinical data about equivalent or similar devices to update the information regarding state of the art or further evaluate safety outcomes presented in the PMCF report.

The equivalent devices selected should be consistent throughout the technical documentation. One must indicate whether this device is an example of equivalent or is a similar device.

However, we can consider PMCF data collected from this device to prove the safety and effectiveness of the device under evaluation. Again, a quick review of pertinent sales literature can often be surprisingly helpful.

Assessing the resulting impact on the technical documentation

Proper Follow-up, evaluation, and analysis of relevant clinical information from the clinical evaluation report during the PMCF phase.

The results in considering aggregate data from each PMCF activity of the device. The results from similar or equivalent devices that affect the technical documentation should be presented here.

If not, the manufacturer must state that the clinical evaluation report and the risk management file do not contain any relevant clinical information to be considered in this plan and the specific reason(s) for the omission.

Last but not least, manufacturers must elucidate whether the clinical data from the device under evaluation still conforms to commonly applied specifications and applied harmonized standards and guidance listed in the PMCF plan.

The impact of data aggregated from each activity attributed to this MFMF evaluating device and the results from comparable devices that affect the technical documentation should be reported here. The manufacturer must inform us whether the ‘concept evaluation’ or any documentation found in or for their risk management project does not include important clinical information to be considered in this.

Manufacturers have the duty to determine whether the collected clinical data from the device under evaluation conform to applied universal standards or apply uniform standards listed in that policy. The results must likewise be presented to the PMCF planners.

PMCF documentation requirements, including potential conflicts of interest disclosures

The manufacture undertaking this PMCF research should complete adequate documentation for inspection for regulator approval. These requirements usually include an inquiry plan to study the study station, informed consent forms from patients, device use instruction, CE certificate, and normally study document certification. Consequently, reviews of the document requesting evidence of a conflict of interests require such confirmations. If a potential CoI is identified and a co-interceptor may apply, he should explain exactly what such an investigation involves and justify his involvement in the investigation.

Our Thoughts

In conclusion, a prerequisite for effective planning, budgeting, and seamless execution of PMCF activities; is an in-depth understanding of its constituents and its regulatory requirements. This includes –

  • Firstly, relevant linkages to Clinical Evaluation Report,
  • Secondly, risk management files
  • Thirdly, Periodic Safety Update Report (PSUR),
  • Lastly, the summary of Safety and Clinical Performance (SSCP where applicable).

A thorough, comprehensive, and complete presentation of post-market clinical data in a proper format are mandatory. This will enable notified bodies and competent authorities to find the information they need quickly. Additionally, this will also ensure safe and effective medical devices in the market, reducing the risk of recalls and scandals. Finally, a well-organized, well-referenced actual-world and cleanly presented PMCF can enhance the reviewer’s confidence in the overall skills and competence of the applicant.

Our team can assess the PMCF study requirements for your device.

The MDR emphasizes Post Market Clinical Follow-up and introduces changes to the procedures for demonstrating PMCF compliance. Our consulting services in Europe and the United States are skilled as PMCF researchers in clinical data analysis. Would you please get in touch to find more information about learning through PMCF? Explore our MDR RESOURCES CENTER for details – how to get the new MDR. Welcome to the center: Medical Device Regulation Resources.

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