The European Commission has asked us to become advisors on a future of medical devices EU parliament process. We are representing on behalf of UK industry on Trade and Innovation.
Please let me know your thoughts on the following four issues:
- Is the European regulatory framework appropriate?
- What are the main market access challenges and how would you reduce the technical barriers to trade between member states?
- Is it necessary to improve international regulatory coordination?
- Is counterfeiting a significant issue for medical devices?
However any observations on selling into Europe would be more than welcome.
The Medical Devices Directive is an adequate tool for ensuring safety and performance of medical devices placed on the European market. The problems have been in its correct implementation by European Member States. Much can still be achieved by all stakeholders to ensure we have a common approach to its correct implementation.
Rod Palmer of - Performance Health Products - 15:03:12pm Oct-30th
Individual countries have additional approval regimes ranging from the understandable technical (Germany, TUV approval, etc.) to the opaque and impenetrable (France). These are trade barriers in disguise, barriers that CE marking was supposed to eliminate.
And is there a danger that endless, needless refinement and complexity will result in an expensive and debilitating burden for SMEs? Yes!
Trevor Lewis of - Medical Device Consultancy - 10:40:51am Oct-28th
There is a need for the methods of paying for all types of devices to be better understood throughout Europe and it made easier for manufacturers to access the requirements, especially as evidence-based purchasing and e-procurement become more commonplace throughout the Community. The European regulatory framework for most medical devices works very well and is a flexible system that allows manufacturers some choice in the conformity assessment route chosen to achieve CE marketing, this is good for both large and small companies, especially startups. The recent Revision of the New Approach brings the processes for CE marking closer to those established and used to good effect in the medical device sector.
Andrew Davidson of - DTR Medical - 18:22:53pm Oct-27th
Areas of concern for us are 1) Development of local registrations - here I know at least one country has created non tariff barriers that do not seem to take CE marking as it should be. This seems wrong and makes it harder to operate as a new SME with export intentions; 2)Poor payment record - I hear horror stories about some public hospitals in certain countries taking up to two years to pay, this contrasts markedly with the current UK government policy where payments are now often within 2 weeks from the NHS.
Peter McGuinness of - Chromogenex Technologies Ltd - 16:22:58pm Oct-27th
The biggest challenge we face in Europe is competition from non EU imports which do not comply with medical device regulation, and in some cases have fake CE marks. Despite this they are being sold openly and cheaply across Europe.
Kirk Buller of - Binding Site - 14:30:48pm Oct-27th
A big issue for us is Vigilance reporting. Whilst the Competent Authorities do talk to each other, a company can end up having separate correspondence on the same issue with the CA in each country where the product is sold. The eventual adopting of the Eudamed database might improve this, but for political reasons it is likely to remain.
Trevor Lewis of - Medical Device Consultancy - 16:30:16pm Oct-22nd
The differences between pharmaceutical and device regulation has been discussed at length by ABHI and Eucomed, the need is to keep the regulatory frameworks independent of each other and not attempt to merge them or absorb their management completely into the pharmaceutical regime.
