Medical Device Regulation Eu vs USA: What does it all mean for the clinician?
Here at medlatest we find ourselves frequently drawing attention to the contrasting regulatory landscapes on either side of the Atlantic. The usual and perhaps inevitable conclusion we come to is that it’s a quicker, simpler and cheaper process this side of the pond than it is in USA, evidenced repeatedly by companies gaining CE approval, effectively marketing approval often years earlier and with a lower or at least different burden of requirements in Europe than over the pond.
As a clinician, you need to decide whether you find it reassuring that products you use have been approved through “a process” or whether you are concerned that FDA “has a higher bar and therefore shouldn’t we?”. In this context, remember that the Medical Devices Directive, governing assessment and approval of the products you use in Europe did not exist twenty years ago and that products you use today have been subjected to a sensible and perhaps more pragmatic approach than that adopted over the water.
Regulatory matters don’t stand still in Europe. In fact European Medtech industry representatives, rather than being simply strident defenders of their industry are actually “inside the tent” with regulators and have a voice that is balanced, reasonable and still working on the basic principle that safety and patient benefit are two sides of the same coin. In other words keeping products off the market may be the ultimate way to ensure patients avoid any safety issues related to their use, but in so doing patients would be denied the benefits of new technologies.
European Medtech industry has proposed regulatory changes
This week the European medical technology industry, in the form of its representative, Eucomed, has outlined in a position paper its proposals for shaping a renewed legislative framework for medical devices in Europe. The document is probably best summarised in the words of Eucomed’s Director of Regulatory and Technical affairs, John Brennan who states that: “The decentralised approach, which is the essence of the current system, should remain a basic principle of the future legislative framework for medical devices in order to preserve safety, flexibility and pace. By improving the regulatory framework for medical devices through the six solutions outlined in our position paper, we believe Europe will become stronger in many areas. Patients will continue to have the fastest access to safe, value-based medical technologies and innovation will continue to flourish in Europe which is good for jobs and the economy. In these challenging times of constrained public budgets and ageing populations, it will be the innovative solutions in healthcare delivery that will help tackle these challenges.
In essence the paper suggests that industry recognises the need to modernise and strengthen the current medical devices legislation in Europe and believes this should be done through coupling more enhanced Member State engagement with better European science-based coordination and management of the regulatory system.
The six fundamental tenets
1. Only the best Notified Bodies (the regulatory footsoldiers, working with companies, reporting to competent authorities and responsible for implementing the rules)
2. One approach to vigilance and market surveillance
3. Strengthened harmonised standards
4. Consistent implementation of guidelines
5. Increased transparency
6. An integrated approach: better coordination and management.
These six points are expanded significantly in the full report which can be found here.
Summary
Eucomed claims that changes proposed in the paper should lead to a smart and efficient legislative framework that is consistently implemented across the EU and guarantees high quality healthcare, patient safety and rapid access to the latest value-based medical technologies.
The suggested framework, it is proposed, will encourage research and innovation, and reduce administrative burden, in particular for SMEs who are the backbone of the medical technology sector. As a clinician, that has to sound like a balanced approach doesn’t it?
Source: Eucomed, medlatest staff
published: November 25, 2011 in: Products, Regulatory