On a straight path to the market

An evaluation by the EU Commission of the certification status under the MDR revealed that most product files submitted to notified bodies have significant deficiencies. Manufacturers and notified bodies therefore take one or more loops until they reach their destination – an MDR-certified product. One way to avoid these costly detours is to carry out specific analyses of the technical documentation created at an early stage.

What can’t be planned – or maybe it can

For new developments, it is necessary to draw up a business case, i.e. a cost-benefit plan. The same would also apply to so-called “remediation” projects, in which the existing product file of medical devices has to be adapted in accordance with the current regulatory requirements.

But what is the exact cost structure here?

Firstly, there are the internal costs, which can be determined based on the company structure. Then there may be external costs such as laboratory costs and costs for clinical trials, which can certainly be roughly estimated or enquired about during the feasibility phase of a project. And then, of course, you will need a notified body (except for Class I/Category A), whose certification costs will also add to the pile.

According to the MDR and IVDR as well as the MDCG 2023-2 MDR form for the presentation of fees, notified bodies must disclose their fees in a standardised manner, which enables comparability of costs. Unfortunately, not all notified bodies have yet implemented this presentation format for their cost structure.

However, all well-intended assessments can collapse anyway as soon as review loops occur at the notified bodies. More work becomes necessary both internally and at the notified body, it cannot be completely adhered to the time schedule and, in the worst case, receiving the MDR / IVDR certificate becomes uncertain.

According to a survey of notified bodies assigned by the EU Commission, many manufacturers are currently facing precisely this situation. 39 notified bodies stated that in June 2023, only around 21% of the files submitted were more than 50% satisfactory. According to the notified bodies, many of the files are in great need of improvement and therefore incur higher costs than originally estimated.

What else is there to consider?

Unfortunately, the cost estimates are only reliable if the manufacturer has first taken a further, decisive step: an honest look at the technical documentation and its own reflection. It is often only through intensive reviews that it becomes apparent that the supposedly documented product properties are mainly based on knowledge and expertise that is present in the heads of the employees, but not profoundly documented. However, this knowledge is not transferred with the submission to the notified body and therefore cannot be independently verified. In order to honestly compare this existing knowledge with the documented state of knowledge, help from an independent party is sometimes required.

In addition, an inadequate product file structure or a structure that deviates from Annex II leaves the reviewer with a “bad taste” from the start. The notified body will take a much closer look if the structures according to Annex II or specified content in regulatory documents such as the Clinical Evaluation, Risk Management File and Essential Safety and Performance Requirements cannot be found. One can therefore also assume a psychological effect, because if the submission is obviously incomplete, the reviewer’s mood is certainly not the best from the outset.

Lengthy discussions with notified bodies can also cause additional stress for the colleagues involved, as the time schedules are often tight, for certainly the company’s aim is to bring the product on the market as quickly as possible.

Perhaps you are now thinking: if only I had a crystal ball to know what’s coming.

Well, a crystal ball is unfortunately not a valid tool for this case, but the view of one or more independent experts can help to obtain an honest assessment of your own documentation: with the help of a GAP analysis.

How you can benefit from a GAP analysis

As part of a GAP analysis, it is possible to identify gaps at an early stage. This applies not only to actual gaps in the state of the art that you may not be aware of or familiar with. It also applies to gaps that only become visible because personnel who has not been trained for many years automatically closes these gaps through their existing expertise when reading. Therefore, independent parties such as the seleon GmbH consulting team will take a neutral look at your documentation.

  • Is the product description complete and consistent within the documentation according to Annex II and III?
  • Has the risk-based approach been taken into account at relevant points?
  • Does the result match the process required by standard ?
  • Are the clinical data sufficient?
  • Has the current state of the art been covered?
  • Are the basic safety and performance requirements demonstrably fulfilled?
  • Are specific requirements for the product consistently documented?

In contrast to notified bodies, however, we can advise you on which approach you can take to close the identified gaps after performing this analysis.

Gaps in the qualifications of your personnel may also be identified. Through targeted training and subject-specific support in the preparation of your documentation, appropriately qualified consultants can then assist and close this gap through training or their own qualifications in the context of creating documents. The seleon consulting team has altogether well over half a century of professional experience in submitting files to notified bodies. And we are constantly gaining new experience and insights into this task.

Manufacturers can benefit from this wealth of experience when preparing the documentation following a GAP analysis. We also do not shy away from discussions or clarifying dialogue with your notified body in order to find constructive solutions.

Manufacturers of Class I or Class A products should also feel addressed here, even if no notified body is involved, as you may be subject to enquiries and inspections by the authorities. Your state authority has direct access and a precise time schedule and will provide you with an exact outline on time and content. It’s good to be prepared for this right from the start.

Analysing your documentation for the requirements of a 510(k)

Is your focus currently not on the European market due to the introduction of the MDR and/or IVDR? You may have performed a market analysis and realised that the US market is currently of greater interest to you? Especially in the case of a planned 510(k) submission, you should also have a neutral assessment of your documentation carried out in advance .Supplementary GAP analyses for already existing 510(k) files and other submission types are also possible. After all, a 510(k) submission to the FDA usually costs over 20,000 dollars (unless you are a “small business”). And a large number of submissions do not even make it through the FDA’s first review round, which is based purely on formal aspects. In addition, there are more rejected applications when the submissions are examined in detail. Now, with this knowledge, the question arises again: Is the investment still worth it? A neutral GAP analysis of your documentation – whether already in 510(k) format or still structured according to MDR – is always worth it in advance.

The early bird… hopefully doesn’t find any deviations

Non-compliance with legal requirements represents a high entrepreneurial risk, as the costs of providing remedy in a short time are considerably high.

Because the unexpected often happens and Murphy’s Law also comes into play, the authorities are sure to hit an unfavourable time for you – because honestly: when does such an inspection ever fit in?

However, if the child has already fallen into the well, we as consultants can quickly provide the necessary capacities and the corresponding expertise to get your company out of the danger zone – also through active assistance. Further, it can be reassuring for your colleagues and employees to receive external support so that the usually existing internal workload and time pressure will not be increased.

Finally, it should be emphasised that manufacturers do not take on all the regulatory activities (QM system, product files, clinical trials) for the sake of the notified bodies and authorities, but in order to develop safe and effective medical devices and bring them to market with the greatest possible efficiency.

A guided approach saves time and provides creative freedom that would otherwise not be possible.

The regulatory product file provides a deep insight into the background and processes of a medical device and thus enables a future-oriented approach to (further) product development, even if it may have seemed like unnecessary baggage at the beginning of this article. But in future, you and all users and patients who use your product will benefit from this clearly structured documentation.

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.