PMCF SURVEY – How to design a PMCF survey and obtain medical device clinical data

Article 61 of the MDR defines the requirements to carry out a clinical evaluation of a medical device. Further clarifications on how to carry out the evaluation as well as the post-marketing clinical follow up are reported in Annex XIV, part A and B respectively.

With the new requirements on the clinical assessment and on “sufficient clinical data”, Notified Bodies expect to receive clinical data actually meeting the definition provided for by the Regulation.

This means that all data used to support the products’ clinical indications must be available in-house for manufacturers wishing to market their medical devices in the EU.

In particular, Regulation EU 2017/745 on Medical Devices (MDR) has sensibly changed the specific requirements for the PMCF, turning it into a systematic, continuous and essential activity.

The result is that in most cases manufacturers find themselves forced to collect more clinical evidence for each medical device and to keep clinical data collection and analysis always updated for the whole duration of the device on the market.

It is possible to group the activities allowing clinical data collection into four main categories:

• traditional clinical trials,
• registers,
• observational data collection,
• questionnaires.

Specific considerations can be made for each method regarding the quality of the data obtained and, consequently, to plan the kind of PMCF activity based on the specific product.

Surveys, questionable tools

The questionnaires, also called surveys, are one of the most debated tools recently.

This is because the old definition of PMCF, meant as a post market clinical follow up, has raised doubts and misunderstandings on what is actually required to answer the questions: Should a clinical investigation be started? Or an observational study? Could a survey be sufficient?

Actually, it depends on the data one aims to obtain, based on some considerations on the MD intrinsic characteristics, such as its basic technology and functioning, if it is innovative, if its presence on the market is now consolidated, and which clinical information is already available.

PMCF survey can be used to obtain information on a device and on its use by health professionals as well as by patients directly, providing a series of questions to be answered. Of course, the kind of questions and how these are asked will depend on the target population it is intended for.

PMCF activities should be carried out in a rigorous and appropriate way, based on a precise method that is specifically set for the concerned device, in relation to the collection and analysis of clinical data.

In order to comply with the requirements on the PMCF as per the MDR, it is essential to have from the start a clear idea of the clinical path of the device in relation to the claims declared by the manufacturer or that the manufacturer wants to declare.

In this way, it is possible to design a questionnaire suitable to the purpose and valid from the point of view of the data obtained. 

You can find below some of the fundamental aspects that turn the questionnaire into an effective tool to generate clinical data:

Sample size

To be effective, a PMCF questionnaire should include a clinical as well as statistic justification of its sample size. In fact, the sample size sensibly affects the results’ accuracy and pertinence.

Statistic sample sizing should be quite automatic for most clinical teams, as it is an essential step in the investigation planning. However, for less expert manufacturers/sponsors, that have never dealt with clinical investigations, this is a particularly hard step, too often undervalued.

Validated Questionnaires

Many validated questionnaires (or value scales) are available, that can be used to collect data on various research topics. Validated questionnaires are questionnaires whose suitability and reliability in providing a certain kind of information have been verified in the reference clinical sphere. This means that the results can provide useful literature data on the issue of interest and, if correctly applied, they can provide robustness to the clinical data recovered by the manufacturers that can adapt them to their own survey, thus sparing time.

Maintenance of reference standard conformity

Although PMCF questionnaires are not clinical investigations in the strictest sense, and therefore do not need either Ethics Committee’s approval or patients’ informed consent, the collected data should comply with the quality standards provided for by the MDR. This activity should always ensure conformity to the regulation requirements, to the laws on privacy and to the guidelines on data protection.

Selection of a suitable tool to disseminate the questionnaire

Once the type of data to be obtained has been established and the suitable questionnaire has been identified, it is essential to define the medium to disseminate the questionnaire, based on the users it is intended for.

This aspect affects not only the method for the data collection, but also the following analysis and therefore the extrapolation of the clinical data of interest. In this phase, it should be defined how to disseminate the questionnaires: either via a physician (or other healthcare operator) acting as a vehicle, or directly to users/patients.

In the two cases, a different uniformity will be expected in the quality of the collected data, and it is therefore essential to try and organise the survey in such a way as to include as less variables as possible.

Carrying out a PMCF activity by a dissemination of questionnaires can be an excellent alternative to a clinical investigation, especially for low-risk and consolidated-use devices. It is important that the activity is always contextualised in a clinical framework, with the goal of verifying and monitoring the post-market safety and efficacy of medical devices. Each questionnaire is a dedicated project, that is developed on a specific device.

PMFC in Outsourcing

Di Renzo Regulatory Affairs can be of help in the evaluation of the project feasibility, protocol development, processing and analysis of the PMCF data. Our medical device team has developed an effective method to select and process specific questionnaires, scientific rationales to support technical documentation and data statistical analysis.

Written on 01/24/2024 by Sofia Tabacco