Critical analysis of the European Society of Cardiologists' report on medical devices problems, and its proposals for reform

Reader warning: this will be a longer-than-usual post, because I did not have time to write a short one (to cite the many philosophers and writers credited for this quote).

The European Society of Cardiology has issued a report of a policy conference held end of January this year, published in the European Heart Journal on 14 May 2011. The report, entitled “Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: Report of a policy conference of the European Society of Cardiology” discusses a number of case studies of clinical outcomes for certain groups of devices and devices enabled therapies (heart valves, percutaneous coronary interventions, diagnostic imaging, cardiovascular implantable electronic devices and closure of the foramen ovale) to arrive at a number of conclusions and recommendations with respect to the existing regulatory framework for medical devices in Europe.

As a first point, I think it is a very important development that the medical profession makes its voice heard in the debate about the revision of the medical devices rules and it is good to see that it is doing that more and more. Healthcare professionals, as everyone in the industry recognizes, play a vital role in the development and post marketing surveillance of medical devices. Any contributions to the debate from that side are to be encouraged, to be appreciated and to be followed up on where necessary.

On the other hand, some criticism is warranted as well, which I will give below, because the arguments proffered by clinicians reveal a lack of knowledge about the applicable rules and a slight bias towards medicinal products legislation as the only good system to regulate ‘medical’ products. For example, in a recent TV program about alleged corruption in the medical devices industry in the Netherlands, many of the surgeons interviewed made statements about medical devices regulation that were completely incorrect (e.g. ‘There is no regulation in place for market access of medical devices. It is about time that the government moves on that.’). In the recent BMJ publication that discussed the quality of the medical devices system similar incorrect statements are made, e.g. that it s impossible to tell by which notified body a product was evaluated (that notified body can be identified by the notified body number next to or underneath the CE sign). Evidently there is a lot to learn on all sides of the debate. Let’s look at the report.

The case for reform set out in the report is made based on five major issues identified (Complexity of the legislative framework, Regulatory gaps and need to clarify boundaries, Weakness of the clincal data requirements, Accountability of the Notified Bodies and Insufficient use of expert medical advice).

Some of the reasoning underpinning the issues identified is better than other. First, the arguments made about complexity of the legal framework raise the exact same criticism as one could make with respect to the medicinal products framework: too complicated, no uniform application by national authorities and notified bodies, difference of quality between the application of the rules by different actors. The report refers to the pharma framework as a “unified system” that would solve these problems. I think this is only partially true. Even in the case of the even more complicated and more highly regulated pharma system there is difference of application between authorities and authorities sometimes even question each other’s safety assessments (while mutual recognition of those is the core of the decentralised procedure system).

Secondly, the arguments that “some new technologies are not regulated by the existing texts” are just wrong. The report refers to software for diagnostic purposes as an example of such inclarity while this is regulated under the medical devices directive beyond reasonable doubt. Certainly with respect to software the general unfamiliarity on the part of the clinical profession with the existing rules for software that I have discussed before sounds through in this report as well. It further states that borderline products are problematic, because it is not always clear by which directive they are governed. This is true, but certainly not solved by any of the recommendations made at the end of the report. Demarcation issues are inherent to the process of therapeutic convergence between medicinal products, medical devices and advanced therapy medicinal products that we are currently experiencing. It would help in this respect if the authorities would be public in their reasoning for classifying a certain product one way or the other. For example, I really do not understand why the EMA does not make the reasoning for its classification decisions with respect to ATMPs public because the summaries provided presently are not helpful at all.

The third criticism concerns the fact that the medical devices system does not prescribe in detail how and when clinical evaluation must be performed and that there is too much reliance on post marketing registry studies. This is an inherent point of the EU medical devices system and recently point of criticism from the US too (‘EU uses its patients as guinea pigs’). However, it has been empirically proven that this does not lead to unsafer devices being approved.

Fourthly, the report criticizes the accountability of the notified bodies and their differing levels of quality. This is a point that everyone agrees with and will be addressed in the recast. It has also been addressed by the notified bodies themselves through the recent implementation of their new code. However, also in this respect it gets the law wrong on points. It states that the responsibility for approving PMS belongs to the notified bodies rather than the competent authorities, suggesting that authorities play no role in PMS for medical devices. This reasoning is incorrect and appears to derive from the pharma system where approval of the PMS system is part of the marketing authorisation issued. Article 10 of the medical devices directive for example contains a very specific obligation on member states to record and evaluate PMS information.

Finally, “concerns have been expressed that there is dialogue between manufacturers and regulatory authorities but academic clinicians are rarely involved.” This is interesting, because a large amount of criticism directed towards the medical devices industry concerns the perceived tight relationships between the industry and clinicians. Many voices are actually clamoring for less involvement of the clinicians in the regulatory process. The industry, for its part, repeats time and again that it cannot develop products in a clinical vacuum, and therefore needs clinicians’ input, both pre- and post market. The report’s conclusion that “the EC is not involved in individual clinical evaluations or approvals of particular devices (which are the responsibility of member states and NBs) and so there is no coordinated system for obtaining detailed professional advice concerning new high-risk devices.” seems odd, because the new requirements for clinical evaluation of high risk devices under directive 2007/47 require a higher standard of clinical substantiation of the device, which presumes more involvement of clinicians because of increased need for clinical investigation.

In conclusion, the report provides valuable input for the debate but not always a correct reflection of the rules in force, which detracts from the authority of the report to a point. I noticed the same in the recent BMJ publication concerning medical devices regulation, which contains a number of incorrect statements regarding the rules, for example that one cannot see what notified body approved a particular device (incorrect, that notified body can be identified by the notified body number next to or underneath the CE sign). Fortunately recommendation no (12) of the report is that physicians should understand and engage with the regulatory system for medical devices. It is up to the industry I think to take up this gauntlet and engage in more active discussions with the clinicians.

Given the misunderstanding of points in the regulatory system some of the recommendations made are superfluous as there are already part of the EU medical devices system, such as

(3) The classification of each type of device should be based on a detailed evaluation of risks (it is, see the classification annexes of the medical devices directives, although admittedly this is not the case for IVDs yet but will likely be after the IVD directive changes);

(8) Outcome studies after device implantation should be undertaken as a partnership between physicians, companies, and regulators (they invariably are because manufacturers need the input of the clinicians applying the devices and many contract clinicians for this purpose);

(9) Limits to iterative changes should be defined (they are defined in the technical file by means of the scope of the CE mark and the duty to discuss changes with the notified body to determine if the change requires an update of the technical file);

(10) Regulatory systems should retain flexibility for special circumstances (e.g. special indications) (there is, because a manufacturer decides the scope of application of the device in his declaration of conformity underlying the device); and

(11) Manufacturers should be responsible for the clinical evaluation of all class II and class III devices (they are, see e.g. Annex X of the medical devices directive).

The other recommendations show a strong desire to move towards a unified pharma-type system as set up for the EU centralised procedure. I am not sure if that will solve all the problems and it is certainly not where the Recast of the medical devices directives is going as far as I know at the moment. A lot more can be said about this and I have even skipped the interesting discussion on the transparency of technical files raised in the report, which is a problem but one not only related to the medical devices system, see just one of the recent European Ombudsman cases concerning transparency of EMA MA application dossiers.

In summary, the report underlines the need for the industry and the clinicians to bridge the evident gap between them and to talk to each other more, and foremost: to explain to each other how they work, why things are done in a certain way and by what rules they are bound. A better understanding of each other’s perception of the rules and how they should be applied will improve the quality of the discussions about improvement of the regulatory system for everyone’s benefit. Subsequently, improvements can be made on a unified understanding of the rules and improvements required.

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