New European medtech laws will improve vigilance, but could delay approvals
Proposed changes to medtech regulations will tighten the oversight of complicated medical devices in Europe, and while they ought to standardise the approval process, there is a risk that new techologies could take longer to reach market. The process will likely also become more expensive, and manufacturers of more complex devices will be hit hardest.
The new guidelines, which the European Commission submitted to the European Parliament last week, suggest ways to ensure that regulation of medtech is applied uniformly across different countries and organisations, as well as defining in vitro diagnostics as medical devices for the first time and bringing them under the same regulatory umbrella. However, enforcement will still be down to nation states, and the industry group Eucomed has warned that too hard a crackdown would ultimately harm patients.
Unlike drugs, medical devices are not regulated by a Europe-wide organisation, oversight instead being exercised largely by individual national governments, and the new proposals are aimed at harmonising the approval process and device vigilance. Stricter approval conditions, such as larger, longer clinical trials, will apply to the more complicated devices, which tend to be manufactured by the larger firms.
To be sold in the EU, a device must obtain the CE mark. Once awarded in one jurisdiction, this is accepted in the 29 other countries. There are three regulatory regimes: one for active implantables, one for in vitro diagnostics (IVDs) and a third for general medical devices.
For general medical devices, the safest, designated Class I, can be self-certified by the manufacturer, but the other three classes – IIa, IIb and III – require certification by a notified body. These are commercial organisations registered with national governments, which confer on them the power to grant CE markings. Active implantables always require notified body involvement, but most (though not all) IVDs can be certified by the manufacturer.
At present, notified bodies can vary slightly from country to country in the demands they make of companies. “At the moment there is no Commission-level control, so it’s at national level,” says Paul Ranson, head of the life science practice at the international business law firm Fasken Martineau. He explains that once a device is CE marked its safety and efficacy is overseen by national government organisations; for example, in the UK devices are policed by the MHRA.
“Notified bodies should have more consistent standards, and possibly more scrutiny,” Mr Ranson says, and this is something the new changes suggest. The Commission has called for a premarket authorisation for high-risk devices, where member states, industry and other parties gain prior review of notified bodies’ assessments of new Class III devices, and potentially other categories of devices.
“For high-risk devices, in terms of premarket evaluation there will be a need to demonstrate greater safety and efficacy through clinical data, which will be more concentrated at the higher-risk end. It’s IIb and III devices that will probably be under more scrutiny,” Mr Ranson says, adding that these tend to be manufactured by the larger medtech firms.
This greater emphasis on clinical data will make it harder, and more expensive, for companies to bring some products to market, and predictably the European medtech industry association Eucomed kicked against the plans. Approval of a medical device in Europe can usually be achieved more quickly and cheaply than in the US – Eucomed says the current setup is “the world’s fastest in providing life-saving technologies to patients without compromising safety” – and there are worries that this could change.
Eucomed welcomed most of the recommendations, but says deeper scrutiny “will ultimately harm patients” by delaying approval of life-saving technology, and will negatively affect governments and industry, and hamper innovation.
However, it will take time for the new rules to be adopted. “They won’t be fully implemented for quite a few years yet, so people will have time to plan ahead.” The timing of the adoption of the proposals will depend on how quickly agreement is reached over any future amendments to the text, but could potentially come as early as 2014, with implementation, which will require countries to pass laws at the national level, in 2019.
Vigilance and traceability
For products already on the market, there will be reinforced market surveillance, and again more uniform standards. “At the moment very different practices apply to reporting incidents. I think the idea is to be better coordinated,” Mr Ranson says.
Flaws in the regulation of medtech in Europe were highlighted by the Poly Implant Prothèse (PIP) breast implants scandal, where the French company PIP was found to have used industrial-grade silicone in its implants, putting patients at risk, as well as the safety problems seen with the ASR metal-on-metal hips made by J&J's subsidiary DePuy.
The medtech regulations in Europe were already under review when the misuse came to light, Mr Ranson says, but the affair highlighted the piecemeal nature of the EU regulatory vigilance structure; companies will now be required to place unique identification numbers on their devices, allowing any faulty products to be traced and recalled.
This should address the difficulty – and in some cases, impossibility – of finding patients who had received faulty products. While there could be short-term pain, the implementation of uniform standards is something "the industry and everybody else is keen to happen”, says Mr Ranson.
To contact the writer of this story email Elizabeth Cairns in London at [email protected]