It’s taken a while, but following last year’s issuing of proposed changes to the European Medical Device Directive, industry body Eucomed has responded with its concerns. The biggest one seems to be that the Notified Body controls can only work if these entities are themselves better.
The European medical technology industry, through its representative body Eucomed, has responded in detail to the European Medical Device Directive proposal. The full release can be found here. In essence Eucomed is welcoming many of the recommended measures, but in some areas it clearly doesn’t believe the recommendations go far enough, which is something of a surprise given the earlier concerns that things were heading towards a burdensome PMA process.
In particular Eucomed is not a big fan of the proposed scrutiny procedure, which places more onus on Notified Bodies to perform regular and thorough checks. It likens this approach to “looking for a needle in a haystack”, and says it would prefer controls that prevent the needle getting into the haystack in the first place. To do this, it proposes better Notified Bodies in the first place, coupled with a system that demands clinical experts review clinical data.
Eucomed says the current European system is known for providing its citizens with timely access to safe technology thanks to the effective decentralised device-specific approval system. It’s clearly keen not to throw out the baby with the bathwater by imposing root and branch changes, noting that the current system makes medical devices available to patients 3-5 years earlier than e.g. in the United States without compromising safety… although one could argue that if that was truly the case we wouldnt be seeing the need for any changes at all.
Back to the Notified Bodies, which are clearly pivotal players in any vision of the future. Eucomed is advocating more stringent control measures on Notified Bodies, which it says is more important than just increasing check performed by these bodies. Couple this with measures to ensure that the clinical evidence for medical devices is properly reviewed by independent clinical experts, and it says the result would be a more systematic approach than that which is currently on the table.
Eucomed’s press release goes on to revisit the seven areas it would like to see forming the focal points of the new regulatory framework, which we’ve covered before, but which notably include greater transparency of clinical data and measures to improve traceability of devices.
Eucomed Chief Exec Comments
“The proposed scrutiny procedure is a ‘needle-in-a-haystack’ approach which should be replaced by a systematic procedure that prevents ‘the needle’ to land in the haystack in the first place. Only then will we successfully increase patient safety and prevent unnecessary delays of medical devices reaching patients. We suggest a systematic control procedure that makes sure we increase the safety of all medical devices, which is in the end the collective objective of all stakeholders. We look forward to continue our discussions with policymakers and other parties and are confident that patients in Europe will be the winner in the end” says Serge Bernasconi, Chief Executive Officer of Eucomed.