The EU’s system for regulating medical devicesBMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e7126 (Published 24 October 2012) Cite this as: BMJ 2012;345:e7126
- Peter McCulloch, clinical reader in surgery
The regulation of medical devices in the European Union has not had a good year. No sooner was the controversy about metal-on-metal hip prostheses beginning to die down when the PIP (Poly Implant Prosthèse) breast implant scandal came along to further undermine both public and professional confidence in the regulation of devices. In a linked BMJ investigation (doi:10.1136/bmj.e7090),1 Cohen follows up on previous investigations to once again target the weaknesses of Europe’s medical devices regulatory arrangements and ask whether the system is fit for purpose.2 3 The president of the Royal College of Surgeons is among those who have joined the chorus of disapproval.4
A straightforward description of EU device regulation often elicits an incredulous response from clinicians who are unfamiliar with how it works (and that is most of us) and the question “How could this have come about?” The current system, which is based on directives 93/42/EEC, 90/385/EEC, and 98/79/EC, relies on 76 “notified bodies” to evaluate the safety and reliability of clinical devices and issue the “CE mark” that allows a device to be marketed in the EU. These notified bodies are private companies that enter into contracts with manufacturers. The data reviewed by these bodies, the tests they require of applicants, and the results of these tests are therefore subject to commercial confidentiality. Notified bodies do not even have to tell the national authority that is responsible for supervising them when they issue a new CE mark. The CE mark certifies that a product meets certain manufacturing standards and is safe when used as designed. There is no requirement to show benefit or efficacy, and the safety certification does not have to be based on clinical data. In short, the system is fragmented, privatised, and largely opaque; safety is dealt with in an unsatisfactory way and efficacy not at all.
As to how such a system evolved, the story is in fact, quite simple. The initial and primary goal of the system (and the original core mission of the EU, or European Economic Community as it then was) was to harmonise national regulations to reduce barriers to trade, rather than to protect public health.
The notified bodies lie at the heart of the problems with the current system. Critics agree that they vary widely in quality and diligence, and that most are reluctant to demand clinical data and lack the capacity to challenge or test the data against expert advice. The notified bodies have also been accused of failing, in the main, to put adequate plans in place for postmarket surveillance. The ability of these bodies to function effectively is questionable because their contractual position represents a conflict of interest—to be effective they must be prepared to frustrate wealthy and powerful manufacturers on whom their livelihood depends.
The EU recognises that the current system cannot survive unmodified, and proposals for reform have recently been put forward.5 Some of these are to be welcomed. Transparency will be enhanced by a new super-database. In addition, the supervision of notified bodies will be strengthened while their powers will be enhanced. However, the basic structure and relationships will remain the same. This is not good enough, and adverse comparisons have already been made with the efforts of the Food and Drug Administration in the United States to update its systems.6
If tinkering with the status quo is not enough then what, realistically, are the principles that would underlie a satisfactory system? It is important not to stifle innovation with extra costs and delays, and enthusiasm for creating more government bureaucrats is currently at an all time low internationally. However, it is reasonable to suggest that patient safety, not trade, should be at the heart of the system. To achieve this goal, agreement is needed on a universal set of clear and well understood standards of clinical evidence for regulators to apply. Such standards should be appropriate for the stage of innovation reached, but they should also provide as much protection for the patient as that stage allows. Evidence should also be open to public scrutiny, in contrast to the current situation.
This may also be the right time to propose the radical idea that devices, like drugs, should require evidence of efficacy as well as safety before being given a full licence. The implications of this may be far reaching but would probably be beneficial for industry as well as for patients. A system of applying a hierarchy of evidence based on the stage of innovation, as currently proposed for surgical procedures,7 would inevitably lead to a provisional licensing framework, where devices could be marketed only in the context of studies to collect further evidence. However, once this phase was completed, devices should in fairness have similar time limited protection from competitors that have not undergone this process as drugs do under patent protection. This would probably reduce the problem of poorly researched “me too” devices seen in several areas while increasing the profitability of devices with good evidence of safety and efficacy.
Although such radical changes to the regulatory processes would be costly, a new system that improved scientific evidence of safety, required evidence of efficacy, and rewarded responsible innovation with protection against piracy would be well worth considering.
Cite this as: BMJ 2012;345:e7126
Competing interests: The author has completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declares: no support from any organisation for the submitted work; PMcC has applied for a grant from the Medical Research Council relevant to clinical evidence and device regulation; he received grants from the Human Tissue Authority, Medtronic, and Johnson & Johnson to support the first IDEAL meeting in Oxford in Dec 2010; he also received travel and accommodation expenses from the Food and Drug Administration for a meeting in December 2011 to discuss IDEAL and the relevance to reform of the FDA regulatory systems for devices; no other relationships or activities that could appear to have influenced the submitted work.
Provenance and peer review: Commissioned; not externally peer reviewed.