Next week, the European parliament will vote on proposals to streamline and tighten the regulation of new medical devices, and the challenge will be to improve standards and increase device traceability without strangling innovation.
While it is impossible to say exactly what will transpire, it is clear that the most radical proposal – creation of a single Europe-wide agency similar to the US FDA – is a non-starter. “The original idea of the European Commission was to introduce some kind of preauthorisation procedure, as with pharmaceutical products,” says Vincenzo Salvatore, senior counsel in the Brussels office of law firm Sidley Austin. “As of today, it’s quite clear that no preauthorisation procedure will be introduced.”
This will be music to the ears of Serge Bernasconi, chief executive of the European medtech industry group Eucomed. “A draft report called for a fully centralised pharma-type approvals system, with the EMA handling approvals of some products,” he tells EP Vantage. “We are fully opposed to that. We’re very concerned that if you do this you’ll create huge bottlenecks, which will slow down the approval of devices.”
The main advantage of the somewhat fragmented European regulatory system over its US or Japanese equivalents is speed. Mr Bernasconi says it takes between three and five years longer to gain FDA approval than a CE mark.
“The US system is frustrating,” he says. “If we don’t watch what we’re doing in Europe, we may end up with a system which is, for innovative products, worse than the US. The US is trying to simplify, and we risk slowing it down.”
If speed is its advantage, the problems with the EU model are its complexity and lack of transparency; the directives governing the process are open to interpretation, and quality of oversight can vary from country to country.
The impetus for stricter regulation comes from social security organisations, insurers, patient groups and bodies representing healthcare professionals, among others. These parties feel that not enough is done in the EU to ensure the safety of devices on the market.
Currently, devices are approved through a network of around 80 agencies – private, government-run or a combination of both – called notified bodies (NBs). These are accredited to give a CE mark, which acts as Europe-wide approval, but are overseen at the national level by the government of the country in which they are located.
The trouble with this arrangement is that the criteria for evaluating the safety and efficacy of devices can vary between NBs, and the standards to which the NBs are themselves held can vary from country to country. Because the current system relies on directives – guidelines, essentially – there is leeway for how governments apply them.
“Directives set only objectives and then give member states the possibility to fine-tune implementing legislation by adapting the legal scenario to the characteristics of their domestic market, whereas when you have regulation there is no room for member states to modify the situation,” Mr Salvatore says.
Mr Bernasconi says that making the laws uniformly stricter will help industry. “Member states have to apply [the regulations]. They cannot transform them, which for us is potentially good news because we know that we will be faced with a similar system all over Europe.”
Eucomed is calling for more stringent regulation of the NBs themselves. “Industry believes … the Commission proposal does not go far enough in terms of raising the standards of a notified body,” Mr Bernasconi says. “If you want to improve the system, let’s raise the standards of notified bodies.”
Eucomed suggests that fewer NBs should be permitted to evaluate the most complex and dangerous products – those known as class III medical devices. “We should put in place a system where to be able to grant CE marking for class III you have to have much higher standards than we have today. You have to have, for example, medical staff on board. You have to accept to be audited a couple of times a year.”
Mr Salvatore says this could well transpire. “What is likely to happen is that monitoring of the activities of notified bodies will be increased in order to ensure that they do the proper work.”
Another area likely to be addressed is traceability. “Today it’s impossible to follow a device: if something happens in France, if you’re in Germany you might never know about it,” Mr Bernasconi says.
One proposal welcomed by Eucomed concerns new traceability requirements, including a unique identifying system to follow a device from manufacture through distribution and sale to its final use. This is intended to ensure that, if the device is faulty, swift regulatory action can be taken.
It is unclear whether traceability requirements will be applied to devices that are already approved but not yet implanted, or whether they will affect new approvals only.
“These are the main features of the new medical device legislation: normalisation, consistency, simplification, traceability, strengthened monitoring of the notified bodies.” Mr Salvatore says.
“Then of course there is still room, because debate is still at the parliament, for adding more safety requirements at the premarketing step, without introducing a real preauthorisation procedure like for pharmaceuticals.”
It seems that the steps device makers will have to take to comply with the likely regulations will not be overly burdensome, but companies are going to have to be be conscientious about meeting them.
“They will have to be much more careful to ensure each single device will be traceable. They must have adequate procedures in place to ensure that they will be able to comply with timely reporting of adverse events to the regulatory authorities.” Mr Salvatore says.
Complying with the new requirements will cost, of course. Staff will have to be trained and organisational change could be necessary in some cases. The changes will affect larger companies more as they bring more products to market, but they will be better able to bear the costs than smaller firms.
Mr Salvatore says that steps may be taken to cushion the blow to smaller companies. “Large companies benefit from an economy of scale, while companies which have one or a few products in the portfolio may face some difficulties. Europe is quite sensitive towards the need to support [small companies], and [it is possible that] a system of incentives may be foreseen at European or national level in order to support these kinds of companies, in terms for instance of fee exemption or reduction in order to get checked by the notified bodies. That will reduce costs.”
The changes will take some time to be felt on the ground. “The new regulations will be finally adopted likely before the end of the mandate of the European parliament which will expire in May next year,” Mr Salvatore says.
Mr Bernasconi disagrees. “If we can do it by the second quarter of 2014 that will be great, but there is a chance that this will go over that time, maybe by the end of 2014, which will mean an application of these new regulations sometimes towards 2017.”
However long it takes to implement and whatever shape the final legislation takes, medtech firms are going to have to get used to the fact that, in Europe, requirements are getting stricter and life is getting harder.