PMCF: Post-market Clinical Follow-Up – Clinical Post-Market Follow-Up

The MDR introduces a number of new terms and abbreviations. One of them is PMCF – Post-market clinical follow-up. In German: The clinical post-market follow-up. But what exactly is it? In this article, we will explain what this term means. You will also learn for which products PMCF is required and what options there are to implement this MDR requirement. Additionally, you can download the templates for the PMCF Plan and Evaluation Report, which are attached to the MDCG documents.

The Medical Device Regulation introduces a number of new legal requirements in the area of post-market surveillance. It’s not that a good PMS system wouldn’t have been able to cover many of the MDR requirements even during the MDD era. But now, expectations are clearer and implementation is more consistent. The MDR now makes PMCF an essential component of post-market surveillance. This is part of a holistic lifecycle model. Throughout the lifecycle of a medical device, clinical data should be continuously generated, evaluated, and used, for example, to update the clinical evaluation.

A PMS system according to MDR includes two subordinate systems. One is reactive, i.e., the classic PMS; the second is proactive. The proactive part becomes significantly more important due to the Medical Device Regulation than it was under the MDD.

The demand for a proactive approach to clinical post-market follow-up and the stronger focus on post-market surveillance have practical reasons. While extensive risk management and a conclusive clinical investigation can be carried out during the development of a medical device, risks often only become apparent during the use of the products in the field due to scaling effects.

For which Products is PMCF Required?

In principle, PMCF is required for all products. However, it is possible to justify non-application within the scope of the clinical evaluation. The question arises, however, why PMCF should not be applicable to a product?

Let’s first look at the following points:

The clinical evaluation should be based on clinical data to demonstrate conformity (Article 61, MDR).
Even with existing clinical data and demonstrated conformity within the clinical evaluation, certain uncertainties remain for almost all products regarding how the product behaves in widespread use in the field. This becomes evident simply because new risks are discovered from time to time that were not previously known.
PMCF requires a systematic approach to keep this remaining uncertainty in the field in view, through the generation and evaluation of clinical data while the product is on the market.
The PMCF measures must therefore be defined in such a way that they are meaningful for the respective product.

Considering the aspects mentioned above, it quickly becomes clear that while PMCF may be cumbersome, it can certainly generate meaningful data. It is understandable that the continuous generation of clinical data with a medical device is complex and poses an enormous challenge, especially for manufacturers who have no direct contact with users.

And even if there is user contact – it is particularly difficult for SMEs, for example, to convince doctors to participate in PMCF measures. Doctors’ time and costs for their efforts are critical factors here.

However, the MDR now focuses on the patient and their safety. The fact that PMCF measures are difficult to implement is therefore not a valid reason for not conducting PMCF.

One possibility is offered by Article 61 (10), which describes that in special cases where proof of conformity based on clinical data is not suitable, a clinical evaluation can be prepared without clinical data.

If you generally do not need clinical data for your product and can justify this via Article 61 (10), then this is, of course, a good basis for not carrying out PMCF measures either. If I don’t need clinical data at the beginning, why would I need it during the market phase?

However, for all other products that require clinical data, arguing against PMCF becomes difficult. In principle, such a justification depends on the type of product, its intended purpose, and its risk class, and must reasonably explain why PMCF is not necessary. The riskier a product, the more difficult it becomes to avoid clinical post-market follow-up, because clinical data tends to be very important in such cases. A PMCF Plan is required in any case, even if the measures themselves have been justified as not necessary. The plan then refers to the corresponding section in the clinical evaluation.

PMCF and Class III as Well as Implantable Products

For Class III products and implantable products, Article 61 on clinical evaluation, paragraph 4, describes possibilities that make clinical post-market follow-up mandatory.

If a clinical investigation has been waived for one of the following reasons, a suitable post-market clinical follow-up plan must be drawn up. This plan must describe the conduct of PMCF studies to demonstrate the safety and performance of the product.

Your product was designed through modifications to a product you have already placed on the market
You have demonstrated that the modified product is equivalent to the product already placed on the market and your notified body accepts the demonstration
The clinical evaluation of the product already placed on the market is capable of demonstrating the applicable General Safety and Performance Requirements for the modified product

Connection between PMCF and Clinical Evaluation

Even under the MDD, clinical evaluation was linked to post-market surveillance. Since the Medical Device Regulation places a stronger focus on the proactive part, i.e., clinical post-market follow-up, this is naturally reflected in its connection to clinical evaluation.

Generation of Clinical Data

Clinical post-market follow-up as an instrument for the proactive generation of safety and performance data is an important component of the holistic concept of the MDR. Data should be generated throughout the entire expected lifespan of the product, for example, to update the clinical evaluation and for the continuous acceptance of the benefit-risk ratio.

Clinical data are information on the safety or performance of a product, generated during its use and originating from the following sources:

Clinical investigations
Clinical investigations or scientific literature on an equivalent product
Other published clinical experience that has undergone peer review
Information from post-market surveillance and clinical post-market follow-up

Updating the Clinical Evaluation

The clinical evaluation is the interface where all available information converges to demonstrate the safety and performance of the product. In this context, clinical data naturally plays a crucial role alongside preclinical data.

The use of medical devices in the field often only reveals problems that could not be identified previously. This data is an important aspect for patient safety, because the benefit-risk ratio is also re-evaluated through the regularly updated clinical evaluation. For this reason, data from clinical post-market follow-up is so crucial for the update.

The MDR states that the clinical evaluation and the associated documentation must be updated throughout the entire lifecycle of the product based on the clinical data resulting from the implementation of the PMCF Plan and the data resulting from the PMS Plan.

If a search for scientific literature and clinical data is now planned as part of the PMCF measures, this is essentially a regular literature search, as also takes place in the clinical evaluation. Doesn’t this offer the possibility of saving work with PMCF measures?

The same literature search conducted in the clinical evaluation can, for example, be carried out annually as PMCF measures. This way, you always maintain an up-to-date overview of this data. However, if the data doesn’t really change and no new insights are gained compared to the clinical evaluation, then I don’t update it either.

The efforts for literature research, which now arise as a PMCF measure, would in any case be incurred during the regular update of the CER. However, reviewing the PMCF data is probably less effort than updating the clinical evaluation and involving a clinical expert for review.

Thus, due to the MDR requirements to update the clinical evaluation based on data from the PMS and PMCF plans, a reduced frequency of necessary clinical evaluation updates can result. And if an update is actually needed, you have conducted the literature search 1:1 as in the CER. It is therefore easy to transfer this data into the clinical evaluation.

In this way, the clinical evaluation can be updated in accordance with the MDR through a systematic approach, without incurring additional effort.

A popular option is user surveys. While this data has a low level of evidence, it is accepted as a PMCF measure for many established products. It is a relatively simple way to generate data with low costs.

If PMCF studies are truly necessary for a product, the whole process becomes significantly more complex. More on this below in the blog post.

The PMCF Study and other Measures

There are different ways to generate relevant data through the proactive approach of clinical post-market follow-up. We will present some of them in the following section.

PMCF Study

Conducting a PMCF study with a correspondingly robust study design is the gold standard for generating clinical data. Such studies are covered by ISO 14155 and must be conducted in accordance with this standard. Attention should be paid to the selection of study endpoints and statistical foundations to generate appropriate data quality.

The mandatory PMCF Plan is the basis for all PMCF activities and must contain relevant information about the planned measures.

In the future, due to the new MDR requirements, more manufacturers will be obliged to conduct a PMCF study for clinical post-market follow-up.

Should you require support in planning and conducting PMCF studies, please feel free to contact us.

User Observation / Survey

Surveying users, e.g., doctors, can provide helpful information about a product. It is important to ensure that user observation is clearly distinct from a study and that no patient data requiring informed consent is evaluated.

PMCF Templates

The Medical Device Coordination Group (MDCG) has provided helpful documents for the standardized documentation of clinical post-market follow-up. These include useful explanations as well as two templates that should be used.

You can download the PMCF Plan Template here.

You can download the PMCF Evaluation Report Template here.