More than four years after they were first proposed, rules designed to improve the safety and traceability of medical devices and diagnostics are finally to come in to force in Europe – in another three years’ time. The European Parliament voted yesterday to approve the final form of new regulations governing devices that will mandate compliance with higher safety standards and could increase the cost of obtaining a CE mark.
The European Commission says that the higher expenditure will be counterbalanced by simplified procedures, a clearer legal framework and the better reputation the system will enjoy, which will presumably make patients and doctors more eager to use non-essential devices. As ever, though, it seems that the smaller a company is the harder and more expensive it will find the task of navigating these new paths.
New rules on medical devices will become law in May 2020 and will apply to all products sold in the EU, whether produced by EU-based companies or not. Key requirements under the new regulations include: that high-risk devices like implants be reviewed by panels of independent experts before they go on sale; that each device be given a unique identifier and be registered in the new, partly publicly accessible database Eudamed, so it can be traced after use; and that patients be given implant cards so they understand exactly which product they have and the clinical evidence behind it.
The regulations will also demand that manufacturers have measures in place to compensate patients in case a device fails, even in the event of the company going bankrupt. There will be random inspections of manufacturing sites, and notified bodies – the agencies accredited to give CE mark – will also come under increased scrutiny, and will have to employ medically skilled people.
Much of the impetus for these new regulations has come from two medical device scandals of the past decade: that of metal-on-metal hips, which degraded rapidly, necessitating replacement, and the PIP breast implants that were found to contain industrial, rather than medical-grade, silicone. In both cases it proved difficult to tell which patients had had these devices implanted.
All medical devices and in vitro diagnostics will fall under the new regulations, but further legal changes governing IVDs will become law in 2022. This will classify IVDs into one of four risk classes, from A – lowest risk, including specimen receptacles and buffer solutions – to D – highest risk, including tests for potentially lethal transmissible agents or for monitoring the infectious load of life-threatening diseases.
Class B, C, and D IVDs will require notified body intervention as part of their approval process. Counselling will also be mandated for patients undergoing tests for life-changing conditions.
Many if not all of these new requirements will cost companies money. It is expected that notified bodies, for example, will increase the fees they charge, to pass the costs of hiring new experts and reviewing more devices on to their clients.
The European Commission says it has put measures in place to soften the blow for SMEs facing these greater expenses; for instance, when it comes to the requirement for a company to have a war chest to compensate patients harmed by faulty devices, this will be “proportionate to the risk class, type of device and the size of the enterprise”, potentially suggesting that smaller companies need put less money aside than their larger counterparts.
Even so the new regulations will put companies under pressure. The lobby group MedTech Europe warned of the “amount of effort needed from all parties to implement these revised rules" and called the three-year transition period “tight”. It stated that steps must be taken to increase notified bodies’ capacity so they can “handle the enormous flow of … dossiers that these regulations trigger”.
These new changes will mean an upheaval for the industry but, if they can be implemented successfully in the time given, do seem likely to improve patient safety. At that point, another question will surface: how long will this regulatory framework last before a new one is proposed?