This article is part of our special report Medical devices regulation.
As the EU regulation on medical devices is under review, much remains to be done to reassure European consumers about the safety of these products, argues Monique Goyens.
Monique Goyens is director-general of BEUC, the European Consumer Organisation, which represents 41 national members.
“Medical devices”. Such an obscure name does not do justice to these lifesavers which help people breathe, walk and see. The wide array of medical devices vary in terms of both size – from contact lenses to MRI scans; and in terms of risk – from low in thermometers to high in pacemakers.
Medical devices should be safe, effective and bring benefits to consumers. But when they are defective they can have serious harmful and deleterious effects on patients’ lives.
Such misfortune befell thousands of patients most recently with the infamous breast implants manufactured by PIP. Shortly after, defective metal-on-metal hip implants also made headlines for releasing abnormal amounts of iron in patients’ bodies.
It is necessary to learn from the past and restore consumers’ trust in medical devices.
While ongoing discussions between the European Union and the United States over a free trade partnership have raised a few eyebrows (including ours), the EU would be wise to follow the US lead here. Across the Atlantic, medical devices are strictly assessed before entering the market.
The situation in Europe is entirely different. To put it bluntly, patients are considered as guinea pigs. The fact that some devices never authorised in the US have emerged on the EU market only to be later withdrawn in the wake of safety problems speaks for itself.
Pre-market assessment in Europe is flawed for a number of reasons. Controls are performed by 'notified bodies'. In most cases they are private companies acting only as service providers to device manufacturers. Notified bodies operate without a public health mandate comparable to that of the US Food and Drug Administration which is responsible for authorising devices’ entry to the US market. Notified bodies should be specialised in a limited number of devices in order to excel.
Accordingly, we believe that a central, European body with a mandate to protect public health – like the European Medicines Agency – should play a greater role in the pre-market assessment of high-risk devices at least.
In addition, more and better clinical data is needed to ensure the efficiency and safety of medical devices are fully proven before access to the market. In order to increase transparency, all clinical investigations should be registered and their results published.
Furthermore, the fees a device manufacturer pays to notified bodies need to be transparent. Only full transparency will restore consumers’ confidence.
Patients have the right to better information on medical devices, on both their benefits and their risks. This is why we call for more information on the 'implant card' given before surgery and on all self-testing devices, which are clearly on the rise across Europe. The current efforts to enable consumers to report an incident quickly and easily are promising.
At present some products are considered medical devices in one country, while in others are classified as pharmaceuticals, food or cosmetics. We need to see the introduction of an EU multi-disciplinary Expert Group tasked with giving binding recommendations on the classification of these 'borderline products'. That way, consistency could be ensured to all consumers across Europe.
The Internal Market and Consumer Protection Committee at the European Parliament recently made headway by voting in favour of mandatory liability insurance for all manufacturers as well as more thorough information for patients.
All the decision makers involved in the overhaul of the medical devices regulation should work towards a legal setup which enshrines proper pre-market assessment and comprehensive market surveillance.
The Lithuanian presidency and Council of Ministers have parts to play in speeding up the process and we hope both will live up to consumers’ expectations so Europe can resort to medical devices with peace of mind. Peace of mind and body, as the saying goes."