Medtech has traditionally required fewer clinical trials than pharmaceuticals, but changes are on the horizon for the regulatory processes in the European Union, which may mean more of a focus on studies in patients. Suzanne Elvidge investigates the makeover
The three key pieces of European legislation for medical technology have been in place since the 1990s. Under these, manufacturers of medtech need to show conformity to the directives – essentially that their products are safe and work as intended.
‘All devices need to conform to the essential requirements of the directives by presenting appropriate clinical evidence, but companies only need to carry out medical device clinical trials if there are no other means available to show conformity, for example, studies for similar devices in the literature,’ says Dario Pirovano, Senior Regulatory Adviser, MedTech Europe.
Once a company can show that it meets these directives, then it gets its CE mark but, of course, this is only the first step. ‘Getting the CE mark doesn’t automatically make the device eligible for reimbursement, as the requirements differ across the member states – for example, some countries might require medical device clinical trials,’ says Pirovano.
In November last year, the UK government announced a commitment to reviewing patient access to innovative devices with its plans for the Innovative Medicines and MedTech Review. This includes looking at how new approaches could speed up access to innovative products for NHS patients, particularly through collaboration between companies and regulatory and evaluation bodies.
Although things can be slow in Europe, the system compares favourably with the process in the US. Independent and approved notified bodies carry out European approvals, whereas the process in the US is centralised. According to Professor Pascal Verdonck, CEO of MedTech Flanders, the US process also has much more of a focus on effectiveness and a greater requirement for clinical trials, meaning involving more patients in longer studies.
‘The European process is much more flexible than the US, and this has allowed more improvements and innovation in medtech in the EU. We have seen some devices available here up to three years earlier than in the US,’ says Pirovano.
Things are changing in the EU. It is revising its regulatory framework for medical devices, and this includes putting more emphasis on the clinical aspects, with an aim of aligning the enforcement of rules more closely across the EU member states. These changes are likely to reduce the possibility of manufacturers of higher-risk devices just being able to refer to the literature to show conformity.
‘I believe this [revision] is in response to health scares such as the Poly Implant Prothèse [PIP] breast implants. While these were harmful, directives shouldn’t be in response to single cases,’ says Professor Verdonck. ‘Politicians also need to listen to the voices of small companies and to the opinions of medical device experts.’
The changes are likely to align the medtech approval process more closely with the EU Clinical Trials Regulation for Medicinal Products that was put in place in June 2014. ‘We’re hoping that these changes won’t mean a specific requirement for clinical studies in all medtech applications – particularly, if they ask for randomised controlled trials. I can’t see that always being appropriate for devices,’ says Pirovano.
The new legislation is still under discussion, with the hope that the views of the European Commission, European Council and the European Parliament on the proposed text can be consolidated in a compromise document around the end of 2015 or early 2016, according to Pirovano, but as he adds, nothing is yet set in stone. ‘It depends on how easy will be to find a compromise!’
Bringing in the new legislation will require a huge effort from the manufacturers and the notified bodies to the member states and the health systems, and a lot of resources. The vast majority of companies involved in medtech are small- and medium-sized enterprises (SMEs). If the new legislation requires randomised controlled trials, which are very expensive, Pirovano suggests that this could have a huge effect on the industry, as small companies will struggle to meet the costs. This would have an impact on the ability of SMEs to survive, which would affect the market and the availability of products. Competition maintains affordable prices, and losing these companies could reduce the industry to just a few big players facing little competition. ‘SME medtech companies are major innovators, so losing these could limit the availability of new and innovative diagnostics and treatments,’ says Verdonck. ‘Medical devices are not drugs, and they need to be treated differently.’
There is also an ethical issue with carrying out controlled trials for medical devices, as Pirovano explains. ‘If you have developed an innovative stent or other device and there is no competitor, what do you compare it with?’
However, there will also be positives aspects to the changes in legislation, as tighter controls and more medical device clinical trials will improve the safety and effectiveness of medtech. ‘Adherence to standards is a tool for embedding a culture of excellence, which means better products developed right first time (and thus quicker). I acknowledge that clinical evidence is costly to obtain and so this might make it harder for some tech startups to get off the ground. Also, some products in the market might be more expensive as a result of meeting more stringent clinical requirements. However, when people’s health is at stake, we should have products that are safe, efficacious and value for money,’ says an industry expert.
The biopharma industry has faced major challenges in clinical trials – the rate of drugs failing when they move through clinical trials is high, and the cost of development has skyrocketed. If there is a move towards more medical device clinical trials, the industry could learn a lot from innovations that are already taking place in biopharma. Some advantageous practices include co-clinical trials – running animal and human studies in parallel, to allow the animal research results to support and inform the human studies, or adaptive designed clinical trials where researchers can modify one or more criteria as the study goes along, based on feedback from doctors and patients.
The existing European legislation has been in place for 20 years or more, and medtech (and technology as a whole) has changed vastly since then. The safety of patients is paramount in the development of both drugs and devices. As well as being a challenge, the new legislation could be an opportunity for the medtech industry to learn from the US medtech process, and from the pharmaceutical industry as a whole, to develop new ways to ensure patient safety, as well as the best possible clinical outcomes, in this fast developing and exciting field.
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