MEDICAL DEVIC E S
Standardise data collection Manufacturers are advised to organise data in a consistent fashion across all devices, medical indications and target population. Developing a standardised approach to data identification and assessment will prove effective in the long run, as it facilitates evaluating existing clinical data, contextualising and keeping track of risk factors, complaint trends, recalls or changes in specific marketing regions, as well as prioritising at a later stage. For instance, different complaint trending methods can be employed based on device family, risk classification or target population. Alternatively, the same complaint trending method can be used while defining the threshold for tolerability in a different way. An additional benefit of harmonised processes is that the clinical story of the product will be consistent across all documents in the submission and documents supporting ongoing compliance.
Review available data
Standardising data-related processes will also help in analysing the quality and relevance of available data and comparing it to the requirements. This practice, together with revenue, certificate expiration timelines, likely lifecycle, market strength and number of devices in need of data remediation will allow manufacturers to determine which products to prioritise, but also to evaluate the compliance effort needed for each device.
Evaluate individual product portfolio
When planning PMCF activities, reviewing product portfolios can allow manufacturers to determine which devices are closest to meeting PMCF compliance requirements and which have a long way to go, and decide how to prioritise remediation efforts. This assessment may also reveal that carrying out PMCF activities does not make immediate commercial sense for all existing product classes, or, by contrast, that it might
be an exceptionally good time to introduce a new product on the EU market. In some cases, manufacturers may not have time to carry out the most appropriate PMCF activity for a product but then can demonstrate how they will remedy this over a multi-year period, and which activities will be employed to generate the required quality data. In some cases, it may be possible to obtain PMCF clinical data during notified body review. Thus, even if a full PMCF report is not available, the data could be used to answer notified body questions.
Pay attention to details Notified bodies have observed that manufacturers tend to not provide enough detail in the documentation, even though the expected level of detail is clearly stated by the Medical Device Co-ordination Group and by notified bodies themselves. All decisions, even the ones that seem obvious to the
author, should be explicitly rationalised, and all supporting documentation, references (such as footnotes to EU MDR, guidance, etc), proposed data and risks, as well as statistical rationales, should be included in the submission. Manufacturers can also use outcomes achieved with other state of the art treatment options as a point of comparison for similar devices, to determine whether they have sufficient clinical data.
Consider what “sufficient” data means
The concept of “sufficient clinical evidence” causes confusion among manufacturers, as it can be interpreted both in a quantitative and qualitative manner. Companies should keep in mind that the amount of data required varies depending on: the risk class of the device, the indication, claims, available data to support the device, and any recent changes in clinical practice or the device itself. Crucially, data must be relevant to the intended use of the device, demonstrate clinical benefit and support the indications and claims. This means that manufacturers should not fall into the trap of including literature that, while it might be relevant to the product, has no bearing on outcomes. In the end, providing strong rationale for why data available should be considered “sufficient” is key.
Involve the whole company Legacy devices are just as affected by the new regulation as new products, so ensuring that other departments outside of clinical are up to speed with the regulatory submission process right from the start is crucial for long-term compliance. To minimise the
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