Safer medical devices demands transparency

Europe’s new Medical Device Regulation is welcome, but there must be more stringent approaches to the role of notified bodies if we are to have faith in the system, writes Michèle Rivasi.
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By Michèle Rivasi

03 Mar 2020

Europe has around 500,000 medical devices that have been inserted into patients. Whether dental amalgams or pacemakers, implantable medical devices are the category of products that pose the highest risk.

While the new Medical Device Regulation will be fully implemented in May 2020, the so-called ‘implants fi les’, published in several newspapers at the end of 2018 showed that the risk of scandal continues and highlights weaknesses in the system for certification and monitoring.

The marketing of medical devices is failing on numerous fronts. First, at the European level during the evaluation and placing on the market; the notified bodies delivering CE labels are not evaluated or regulated.


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Yet once obtained, CE marking enables the product to be sold throughout the EU. These private certification bodies, remunerated by industrialists applying for a CE label, are both judge and jury - a clear conflict of interests.

Abuses ensue, favouring the absence of reasoned regulation by their national supervisory authorities, which simply register, rather than regulate, the notified bodies.

This lack of control in the medical device market is also apparent at the Member State level, with inconsistent and ineffective pharmacovigilance and materiovigilance data.

“The medical device vigilance system is still in its infancy; we must demand an appropriate toxicological evaluation of all medical devices”

In addition, there is an intolerable level of opacity when it comes to data checking, helping hide systemic failures. The succession of health scandals — PIP implants, hip replacements — highlight the failure of the current certification system and the checks carried out by notified bodies.

In the case of PIP implants in France, the German inspection body TÜV did not see that the components of these failed to meet applicable standards.

As regards hip implants, marketed by Johnson & Johnson 2003-10 to 93,000 people worldwide — including more than one hundred in France — these were not reported by the competent authorities.

This laxity in regulation should be partly corrected by the new Regulation, which provides for establishment of a panel of European experts and includes a requirement for ‘clinical investigation’ on any new implant placed on the market.

To date, only a handful of European notified bodies have received their new CE approval to inspect products. The accreditation of the new notified bodies — we are expecting around 20 as opposed to 78 previously — is telling of both the new requirements but also of the lack of will and skills of these bodies to shoulder their new responsibilities.

The fact remains that high-risk medical devices should be subject to the same marketing authorisation procedures as medicines.

Indeed, until now no prior marketing authorisation was required for materials used in medical devices to be placed in the body, raising questions over weaknesses in earlier clinical trials.

Without good epidemiologists, if there are no personnel qualified to assess clinical trials, to analyse the impact of metals on bones or on the blood, then new health scandals seem inevitable.

The medical device vigilance system is still in its infancy; we must demand an appropriate toxicological evaluation of all medical devices and the gradual elimination of carcinogens, mutagens or reproductive toxicants (CMR) and endocrine disrupters (PE).

No prior marketing authorisation is required to place these materials in the body; we cannot be too cautious.

Consider dental amalgams as an example; these cause mercury to accumulate in the body. We know the outcomes of mercury toxicity, so it needs to be removed as soon as possible.

“There is an intolerable level of opacity when it comes to data checking, helping hide systemic failures”

The same goes for certain contraceptive implants, which must now be removed as they cause nickel fragments to diffuse in the body. It would have taken years of complaints and alert by victims for the manufacturer to suspend its marketing.

Europeans are real guinea pigs, insofar as we tolerate the use of invasive medical devices without a prior toxicity test, and we simply accept that they contain CMRs or PEs. It is unacceptable, but decision making is slow.

More generally, risk assessment must be completely redefined: exposure to toxic substances alone is a problem in itself, but the phenomena of multiple exposures generates new concerns.

Under pressure from certain Member States and lobbies, the Commission has rejected the idea of a single public-certifying body for the time being, based on the more stringent model medicinal product approach.

Innovation should not be at the expense of patient safety; we must therefore consider a centralised body - under the aegis of the Commission - that specifically analyses the efficacy and safety of medical devices.

There must also be transparency. Information on the efficacy and safety of medical devices must be made public and medical equipment must be controlled via random checks.

We need complete confidence that the medical device certification bodies, with their key role in marketing medical devices, are genuinely independent and competent.

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