Last week Eucomed Boss Serge Bernasconi issued a blog which usefully fills the silence between the European Parliament’s plenary adoption of new medical device regulatory proposals and their subsequent adoption, which is likely to take place later this year.
Eucomed is Europe’s medtech industry body, if you like the European equivalent of the U.S. Advamed organisation. As Chief Executive Officer MedTech Europe, EDMA and Eucomed, Serge Bernasconi’s voice is always worth a listen. He’s been a contributor and commentator on the evolutionary changes to the regulation of medical devices that have been in train for the past few years. And now, as the rules are getting their final tweaks, he’s not letting his guard down. Indeed, in a newly issued blog on the Eucomed website he’s making sure industry’s voice is being heard right down to the wire.
So what’s he saying? Well, from the myriad components of the new device rules, he’s picking out four for special attention. These are:
Reprocessing of single-use devices: Bernasconi says the Commission’s proposals for the re-processing of single-use medical devices is a sensible one, but it still allows for devices like syringes and urinary catheters to be reused without imposing on the reprocessor the same obligations as original manufacturers. He says that “just isn’t safe for patients”.
Clinical requirements: While in favour of improving clinical data, but is keen to point out that rules that apply to pharmaceuticals should not simply be airlifted across to medical devices. He advocates the “right trial design for the right product – not a one-size-fits-all approach that we copy and paste from the EU pharma regulation”.
Hazardous Substances: Bernasconi admits that he’s not arguing in favour of keeping so-called ‘’hazardous substances’’ in medical devices, but points out that it’s hard to justify the immediate removal from the market of countless essential medical devices like blood bags, simply because there is not yet a suitable alternative to replace the substances they contain. So instead of banning these substances outright, the medical device industry supports the Commission’s proposal to phase these out gradually and weigh the risk and benefit of each product on case-by-case basis until the phase out is complete.
Scrutiny Procedure: This is probably the biggest single change to the regulations, and refers to the way in which Notified Bodies operate to monitor company regulatory activities. Eucomed has long been of the view that the best way to increase patient safety is to ramp up measures to ensure that Notified Bodies are doing a good and consistent job by making the criteria to become a notified body more stringent and encouraging notified bodies to specialise in certain products. Indeed we’ve editorialised on that subject on many occasions ourselves. Eucomed is also “keen to make sure that the analysis of clinical evidence for devices is being properly reviewed by clinical experts, who should be publicly disclosed by the notified bodies”.
And the other piece of the jigsaw is the issue of measures like the unannounced visits, which might just have picked up the PIP scandal, removing the opportunity for companies to hide the evidence of wrongdoing. Needless to say Eucomed supports measures like this too.
But our friend Serge has used the opportunity of his most recent blog to distance industry a little from the somewhat overbearing scrutiny proposals on the table at the moment. What he’s advocating he’s renamed “reinforced control procedures” to reflect the difference and make sure it’s clear that he’s advocating something that builds on current foundations rather than a burdensome new infrastructure.
Find the entire blog here.