Three Tips for PMCF Planning

Three Potential Problems

It is critical to keep the pace of preparation activities going in Post-Market Clinical Follow-Up (PMCF), since the bar for supporting data quantity and quality has been dramatically elevated by MDR. Our work with clients has identified a number of frequent problems, each of which, if not handled, might have serious commercial ramifications. To help manufacturers improve their competitive positioning, this short document attempts to highlight those common problems, as well as a reminder of the three major best practices steps to compliance.

The purpose of this whitepaper is to provide manufacturers with a best practice guidance for preparation, steps and the three key pitfalls which CLIN-r+ is most frequently encountering. Gaps identified in the CER or emerging risks seen in in the PMS process must be addressed in the PMCF plan and in turn affects these upstream documents.

PMCF Potential Problem #1: ‘Sufficient Clinical Evidence’

Perhaps the most common stumbling block for businesses on their way to PMCF compliance is determining just what “adequate clinical evidence” implies. It is critical to recognise that the interpretation of the word ‘sufficient’ involves a balance of quantity and quality.

Do we need 3 patients’ feedback, 30 patients’ feedback, or 300 patients’ input? Is the feedback giving you useful information that you can use to improve your product’s performance? The device’s risk class, indication, claims, available data to support the device, and any recent changes in clinical practise will all influence the responses to these questions. When evaluating clinical articles as supporting data, ruthless rigour is necessary.

We’ve encountered cases where businesses have been persuaded to provide text that is unquestionably about the product but does not examine significant results. Analysing outcome data from high-quality studies relevant to the device’s intended use and comparing the results to similar devices or other therapies is an important part of determining if the device has enough clinical evidence.

PMCF Best Practice Tip 1: Ensure that Data is Assessed and Identified in a Consistent Manner

The next big stumbling block we see in our work with manufacturers is a failure to connect early in the process with departments other than clinical, such as sales and marketing or general management. For PMCF performance and continued regulatory compliance, gaining buy-in from other stakeholder business units is critical.

The importance of cross-functional alignment is due to the fact that this level of examination and clinical evidence applies to both legacy and new products. In fact, legacy devices that have been on the market for a long time are likely to be the most vulnerable to these hazards. “Why do we need to spend money on compliance today for widely established products?” non-specialists in the industry question. The fact of the situation is that the new Regulation requires such clinical evidence. And acquiring sufficient data – both in terms of number and quality/relevance – can be expensive. For these operations, it is critical to align on device priority, submission risk, and all accessible sources of data on a product.

We hope that it is now evident why it is critical to involve other departments in the process and assist them understand why they should care, why they should fund, and the potential business consequences of poor data quality and non-compliance.

PMCF Best Practice Tip 2: Examine All the GSPR Data

• Existing clinical data gaps or emergent concerns should be discovered from Notified Body reviews, Clinical Evaluation Reports, and Post-Market Surveillance and Risk Management evaluations after the clinical data for each device has been collected and compiled.
• Examine data quality and appropriateness – how useful is the information gathered or the literature cited? Does the data back up the device’s safety and functionality, as well as its intended use? Is this the amount of evidence expected by the notified body for this risk class?
• How can gaps be filled in the most effective/efficient way possible? Can SOTA (12), risk level, compliant data, or market experience be used to back them up? Is it necessary to make each indicator more specific? Is there a list of relevant outcomes to back up the clinical benefits? Is there any bias that needs to be addressed? What percentage of it is due to post-market surveillance? Is the follow-up for the entire life of the product? Is the clinical data inclusive of all product variations and ranges?
• Assign ownership, with a defined matrix of responsibilities, first within product teams (tech docs, Instructions for Use, product claims, SOTA (13)), then across Clinical and Performance, Regulatory Affairs, Product Quality, and Sales & Marketing. Recognize the extent to which device-specific requirements exist across the product portfolio. This necessitates collaboration with the PMS, Marketing, R&D, and General Management departments. To begin, the resources allocated to each device will be prioritised according to the certificate expiration date, gap analysis, likely lifecycle (Implants), sheer volume of devices requiring data clean-up, and the product’s position within broader therapeutic systems.
• However, the system must be able to adapt to the specific needs of each product, which will be different. How would you convey the data to an auditor? In terms of classification, range of indications, innovation, or market history, how does your data differ by device? What are the available possibilities based on the device class and clinical gaps? Are there any exceptions to the WET (14) rule, or is a lower data bar acceptable/advisable?
• Inevitably, PMCF planning will expose a number of difficult commercial decisions that must be taken in a short period of time, such as whether or not to keep all products in the present range on European markets. Those who started their preparations early are better able to take that perspective and are less pressed to withdraw market presence.

PMCF Potential Problem #3: Documentation is lacking in detail

Even when making minor changes to existing items, such as adding an antimicrobial coating or changing the manufacturing procedure or material, MDR sets a considerably higher bar for clinical evidence.

The third most common PMCF compliance stumbling block is a reluctance to provide adequate detail in the documentation. Despite the efforts of the Medical Device Coordination Group (15) and the Notified Bodies to make the degree of detail abundantly obvious, far too many businesses fail to do so.

It is vital to ensure that the amount of PMCF necessary, as well as the explanation for it, is consistent with the suggested strategy, which is based on good scientific principles, measurable targets, and statistical planning. Document the planned facts and justification, the underlying rationale vs, the hazards, and finally the references (footnotes to EU MDR, guidance, etc). Furthermore, the statistical justifications for the level of detail and data quality supplied are frequently insufficiently robust.

These are the arguments for why the requested volume and type of clinical data is reasonable in light of the?device’s dangers. Also, try setting up pre-defined action triggers ahead of time. Finally, if you decide not to do something, you must have the strongest possible justification for your decision.

PMCF Best Practice Tip 3: Develop a PMCF Strategy that is Compliant to EU MDR and ISO 14155

Understand your PCMF strategy alternatives, including the cost and effectiveness of each device type, as well as any gaps. Clinical literature reviews need the least effort and money, followed by patient and customer surveys/questionnaires, clinical database information, and clinical RCTs. All of this contributes to the development of the most robust, meticulously documented reasoning for PMCF data inclusion/exclusion, depth, and relevance.

Recognize the best combination of people, systems, and talents for the most cost-effective solution. What activities should be performed in-house, and which should be outsourced? Even when adequately budgeted, skills and resources are in short supply during times of acute market pressure.

What is the relationship between your PMCF strategy and Notified Bodies? “Consultation or guidance to the manufacturer, the authorised representative, a supplier, or their commercial competitor in regard to the design, construction, marketing, or maintenance of the products under examination” is absolutely prohibited for NBs.

Have strong justifications in place for PMCF plans that will withstand examination. Justifications should be based on good scientific concepts and include explicit, measurable goals as well as extensive documentation. The use of economic rationale (exorbitant costs) to rationalise risk-taking is never a good idea. Each PMCF activity should have its own set of business considerations. Timeline of the activity, available budget, risk class of the device, quality of data needed to establish sufficient proof, and whether a general or specific PMCF activity will give the data required are all factors we propose include in the evaluation.

CLIN-r+ Recommendations

Partner early with?Clinical Affairs consultancy?specialised in Clinical Evaluations and PMCF work?to help you tame all your data. A good practice is to create a Clinical Evaluation Matrix (CEM) to outline all your data per indication, claim, safety endpoint and performance endpoints. A well formulated CEM saves time in spotting data gaps and helps identify state of the art benchmark performance and safety to quickly highlight data needs for you PMCF justification.

You will need to team up with various?skilled experts?such as biostatisticians, clinical train design experts and clinical investigation medical writers to help clarify the needs of ISO 14155. These professionals should sign off on your PMCF plan to demonstrate the expertise sought when planning your PMCF. A good sign of a proficient Clinical Affairs consultancy will be having this expertise available to you at anytime you need it. One good question to ask is what design and sample size of patients you would need for PMCF plans. This will quickly highlight vital skill gaps.

Start your PMCF journey by having?suitable processes and templates formulated?to ensure all the required information is being formulated and it adequate. With your first PMCF plans, draught and test the process with a few representative and high-priority devices, piloting and refining it from the drafting of the PMCF plan to the completion of the PMCF report. This will be used to put templates, forms, and processes through their paces to ensure that they perform well across your organisation. It’s also vital to keep in mind that the PMCF process isn’t a one-and-done affair. The manufacturer must think about how the PMCF process interacts with the PMS, clinical evaluation, and risk management processes, as well as how the papers will be updated over time.

This brief article aimed to highlight some of the potential problems that medical device and IVD makers may face in preparing for MDR compliance (and PMCF in particular). Manufacturers can prevent major financial and market access repercussions down the road by ensuring their business has a solid PMCF plan in place. Preparing for MDR and IVDR in a timely manner (even early, if possible) necessitates a balance of in-house and outsourced expertise. Medical device businesses can benefit from partnering with third-party specialists that have both knowledge and experience in this field to build and implement successful PMCF roadmaps.

Source: Clinr-r+