EU parliament has opportunity to give medical devices a 'new lease of life': theparliament.com
Despite not being as stringent as expected, European consumers will be better protected if MEPs endorse the current medical devices law proposal, argues Monique Goyens.
The medical devices directive saga continues, with MEPs set to vote in plenary on 22-23 October. As the final decision will impact upon many patients' lives, it is crucial to run a health check over the current situation.
The "medical devices directive may lead to lower patient safety", former MEP John Bowis now turned president of Health First Europe asserted in a recent issue of the Parliament Magazine. Were this quote to be in my name, I would simply replace "lower" with "higher".
I am assured that MEP Dagmar Roth-Behrendt's report, which has been adopted by parliament's environment, public health and food safety committee, progresses the status quo and strengthens the European commission's original proposal.
If adopted, the proposal would ensure consumer information is improved. The 'implant card', which would give patients information on the device they are about to have fitted, is just one of many advances.
The report also adds a much needed dose of transparency by improving public access to information on a host of issues: clinical investigations, the safety and performance of marketed devices and incident reporting. Transparency is undoubtedly key in empowering consumers and to restoring trust in manufacturers, regulators and doctors.
This being said, to ensure consumers' safety throughout, the parliament should ensure the pre-market checking of medical devices is as robust as post-market assessment is set to become.
The concept of a "balanced approach" permeates John Bowis' piece. For us, the benefits should always outweigh potential risks for a medical device to gain market entry. Currently, the 'CE' marking approved by the much talked-about 'notified bodies' does not guarantee safety to patients.
Besides checking the technical performance and safety of a medical device, it is essential inspectors also measure its clinical efficacy - its potential to bring tangible health benefits to the patient. To do so, manufacturers must be required to produce better and more clinical data.
Because it takes time to produce sound evidence of a device's risks and benefits, demands for safety and providing early access sometimes come into conflict. However, I am convinced it is both possible and necessary to put in place a sturdy system of approval for high-risk medical devices ensuring patients can access life-improving tools without unnecessary risk or delay.
On the one hand, industry-funded research indicates that patients in the United States have to wait longer than Europeans to obtain devices because of their pre-market authorisation system.
On the other hand, peer-reviewed research published in the New England journal of medicine demonstrates by way of real-life examples that such waiting time in the US is similar to - or in some cases even shorter than - main European markets. Unsurprisingly, I treat the first research cautiously and hope the latter can help stir discussions on stronger pre-market assessment.
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