March 13, 2012
Having read Commissioner Dalli’s analysis of the PIP case and the Commission’s plans for strengthening the medical devices directives, it becomes clear that the medical technology industry and the Commissioner share the same view on safety and innovation. “Trust and confidence of consumers in our systems is the basic premise on which all else rest”, says Commissioner Dalli. Specifically for medical devices regulation I would add that we need a system which also incentivises innovation. Only if all boxes are ticked we can come to sustainable healthcare systems throughout Europe which re-instil trust and confidence among Europe’s citizens.
Unfortunately, no system in any sector can entirely guard against fraud or deliberate abuse. Be it in medical devices, pharmaceuticals or food – when fraud occurs, the important thing is to establish the facts and improve where necessary. It does not mean that you change the entire system, especially one that is working well, but that you introduce effective measures to close the gaps. And these gaps are often situated on the implementation side of things. As a result of the PIP case, Commissioner Dalli proposes a 5-pillar plan of immediate action for strengthening the current regulatory framework. We agree with the Commission that work needs to be done on improving the effectiveness of the implementation of the current regulatory framework.
We believe the measures, whilst bringing additional burden to industry, are overall balanced and appropriate, and will have a positive effect on consumer and patient confidence in the system. We appreciate the Commissioner’s view on more stringent and transparent control of notified bodies; the suggestion of random, unannounced inspections and reinforced market surveillance; and the goal of a more coordinated incident reporting mechanism; and traceability of devices.
Currently, the European regulations for medical devices are also under revision with a Commission proposal expected in late spring. As Mr Dalli points out, work on this revision had started already long before the PIP case surfaced and should not now lead to a kneejerk reaction during the revision process. To prepare the current European regulatory framework for medical devices for the next 20 years, Eucomed recognises the need to modernise and strengthen the current legislation in Europe, in particular by coupling more enhanced Member State engagement with better European science-based coordination and management of the regulatory system.
Thus, as these immediate actions will no doubt trickle through to the revision of the medical devices directives, in addition, we believe that the revised system should bring centrally-coordinated oversight with the active involvement of national health authorities, and proper information and traceability. It should maintain the strong points (and there are many) of the current legislation, while remedying identified weaknesses. I firmly believe that only then we will be able to deliver improved health outcomes, coupled with a high level of patient safety while reinforcing Europe’s position at the forefront of innovation in medical technology.
Chief Executive Eucomed
This blog first appeared in Parliament Magazine.Author : MedTech Europe