What to consider when using a PMCF template under the EU MDR
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What is a PMCF template?
A Post-Market Clinical Follow-up (PMCF) template is a standardised template intended to serve as a “one size fits all” guide to developing a PMCF system and associated technical documents.
Templates are often used by medical device manufacturers for support and guidance when developing a PMCF strategy, or when they feel that they do not have sufficient in-house expertise in developing PMCF systems.
A well-designed PMCF template should have sufficient flexibility to accommodate a wide-range of medical devices. It should empower the user to develop a basic PMCF structure that could then be documented in a PMCF Plan before being enacted.
Can a PMCF template be used under the MDR?
Post-Market Clinical Follow-up requirements have changed following the introduction of the Medical Device Regulation (MDR). Under the out-going MDD, requirements for PMCF in many cases were comparatively light, meaning that a template-based PMCF system was often sufficient.
The Medical Device Regulation (EU) 2017/745 fully replaced the MDD on 26th May 2021. It introduced a wide range of changes to the way medical devices are regulated, including a markedly increased level of prominence and scrutiny of PMCF systems. These changes mean that more care is needed when choosing a PMCF template. Often, it may be beneficial for manufacturers to seek advice when working with PMCF templates.
Where can I find reliable templates for MDR Post-Market Clinical Follow-up?
Although many of the existing PMCF templates will fall short of MDR requirements, there are several sources of templates that can be useful when designing and implementing MDR Post-Market Clinical Follow-up systems.
The Medical Device Coordination Group (MDCG) produce a range of guidelines that, unlike the MedDev guidelines, have been updated to reflect changes introduced by the MDR. Guideline MDCG 2020-7 — Post-Market Clinical Follow-up (PMCF) Plan Template - A guide for manufacturers and notified bodies was published in April 2020 and outlines a detailed approach for writing a PMCF Plan. Working to the MDCG recommended structure will help ensure acceptability of the PMCF Plans format and contents when presented to a regulator.
The MDCG guideline still requires manufacturers to conceive of an overall Post-Market Clinical Follow-up design before the template can be effectively used. It is a detailed guide to writing a PMCF Plan; it is not intended to act as a guide to designing PMCF studies.
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MDR Annex XIV Part B contains a useful set of information regarding objectives of PMCF systems and requirements for PMCF planning. It is recommended that manufacturers work through the Annex during planning or upgrading of PMCF systems.
Annex XIV Part B also contains useful information about the sections that must be included in a PMCF Plan. By using Annex XIV alongside MDCG 2020-7, manufacturers should be well-positioned to ensure MDR compliance of their Post-Market Clinical Follow-up system.
Further help can be obtained by contacting dedicated advisers and clinical evidence consultants who specialise in MDR PMCF.
Other considerations when using a template to meet PMCF requirements under the MDR
If you decide to work with a template to develop your Post-Market Clinical Follow-up system and documents, it is also important to consider the following general points:
- 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. An effective template must be designed with sufficient flexibility to adequately address this variability.
- Clinical application. Having a basic, templated structure for a PMCF system is not the same thing as implementing a fully-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. While an effective template can lay the foundations of a fully-functioning system, it takes a wider team or specialist advice to bring this system to life.
- Writing PMCF Plan and PMCF 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 Report. As with developing a PMCF system, correct drafting of these documents requires clinical acumen that goes beyond simple adherence to a standard template.
Effectively implementing your MDR PMCF strategy through use of a PMCF template will require careful template selection against the above criteria. It will also require a careful focus on ensuring availability of the correct level of clinical expertise in order to bring the PMCF system to life and ensure maximum contribution to your regulatory strategy.