Post-Market Clinical Follow-up Template

What are the main reasons as to why you should not use a template for Post-Market Clinical Follow-up under the EU MDR?

What is a Post-Market Clinical Follow-up Template?

A Post-Market Clinical Follow-up (PMCF) Template is a standardised template intended to provide a “one size fits all” strategy for PMCF. Templates have been used in the past by medical device manufacturers who felt unable or unwilling to develop a PMCF strategy from scratch, or who lacked in-house expertise in developing PMCF systems.

A template, in theory, provides a basic structure for a PMCF plan and allows a manufacturer to begin collecting post-release data on a medical device. Under the Medical Device Directive MDD 93/42/EC, requirements for PMCF in many cases were comparatively light, meaning that a template-based PMCF system may have been sufficient.

The Medical Device Regulation MDR 2017/745, fully replacing the MDD from 26th May 2021, introduces a wide range of changes to medical device regulation including a markedly increased level of prominence and scrutiny of PMCF systems. These changes will make it very unlikely that a PMCF Template would be sufficient to meet MDR requirements for any one individual medical device. Manufacturers will need to develop PMCF systems from scratch, drawing upon internal or, if necessary, external expertise.

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Why won’t a Post-Market Clinical Follow-up Template suffice for MDR compliance?

Successfully working with the MDR necessitates a high level of understanding of how the Regulation is structured and applied. The MDR imposes a range of requirements on medical devices, conformity to which must be demonstrated through the production of clinical evidence. Templates are unlikely to provide a useful solution under the MDR because the requirements that apply to one medical device will differ markedly from those that apply to another.

The General Safety and Performance Requirements (GSPRs), detailed in Annex I MDR, comprise a long list of requirements intended to cover the scope of all possible devices. However, it is not intended that all of the GSPRs will apply to any one individual device, with those that do apply being dependent upon the structure, risk levels, application, and method of action of the device. Given the large total number of GSPRs, this produces a high number of permutations of requirements that would be difficult (if not impossible) to adequately address through a general template.

For example, devices that are intended to be supplied sterile must be accompanied by evidence that this is achieved in practice; evidence of this type will have no applicability to non-sterile devices intended for use by lay people, or to software as a medical device. The only reasonable solution is to develop a bespoke PMCF strategy for each individual device, ensuring that relevant GSPRs are addressed while diverting valuable resources away from those that are not.

Other reasons for the inability of a standard template to meet PMCF requirements under the MDR include:

  • Nature of adverse events. It is a requirement under Article 87 MDR that manufacturers collect data on serious incidents and adverse events. The possible range of adverse events differs markedly from one type of device to another, so the system intended to collect such data will need to be constructed around the nature and frequency of such incidences. A standard template cannot be sufficiently flexible to adequately address this variability.
  • Clinical application. Having a basic, templated structure for a PMCF system is not equivalent to implementing a functioning system. Clinical application of a PMCF system requires clinical knowledge — data must be produced, collected, appraised, interpreted and applied correctly in order to generate valid evidence that will pass regulatory scrutiny. This can only be achieved through clinical acumen, not through a standard template.
  • Writing PMCF Plan and PMCF Evaluation Report. Annex XIV Part B of the MDR requires that a plan for a PMCF system is written in a technical document known as a PMCF Plan, and that results of PMCF are captured in a PMCF Evaluation Report. As with developing a PMCF system, correct drafting of these documents requires clinical acumen rather than rigid adherence to a standard template.

What is the correct approach to PMCF under the MDR?

The correct approach to building a PMCF system under the MDR is to obtain the required degree of expertise, either through undertaking training or through engaging with external specialists who have the necessary level of clinical acumen to deliver a solution.

In order to ensure correct adherence to MDR requirements it is necessary to avoid the apparent temptation of templates. Instead, there should be a focus on bringing the correct level of expertise to the process of implementing your MDR PMCF strategy.

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