Brussels, 10/12/2013 (Agence Europe) - Reconciling a higher level of protection for patients while not putting a brake on the availability of equipment for these patients and technological innovation - that is the challenge that the new framework on medical devices has to meet. On 10 December, the EU ministers responsible for this issue held an initial exchange of views on the European Commission's proposal during the Health Council. While opinions diverge as to the need for a second assessment at European level for high-risk devices (such as implants) and the re-use of single use medical devices, all the delegations decided unanimously in favour of the Commission's objectives - in other words, strengthened monitoring of the safety of medical devices and better traceability of products so as to avoid a repeat of a similar scandal to that of the PIP breast implants.
On 26 September 2012, the Commission proposed two regulations to amend the current framework - one on medical devices and the other on in vitro diagnostic medical devices. “The regulations amend a legal framework that has existed for over 20 years so as to take account of technical and scientific progress since then. The proposals must ensure that safe devices - and only those - are marketed so as to guarantee an optimum level of safety for citizens. It must be ensured that innovative devices are made available for health professionals in the quickest time possible and also to preserve the good way the single market works and the competitiveness of the European Union”, said Lithuania's Minister for Health Vytenis Povilas Andriukaitis. Work is progressing but the proposals are both long and complex on the technical level, the minister said, hoping for positive progress under the Greek Presidency of the Council of Ministers of the EU. “If we do not move forward to a review, crucial issues for the safety of patients will not be settled sufficiently. The scope of the legislation must be clarified and the method of governance for the system and its transparency must be strengthened. The obligations weighing on the notified bodies, particularly as regards unannounced audits, must be strengthened. As regards ranking the devices according to risk, they must all be adapted to take account of technological progress”, said European Commissioner for Consumer Policy Neven Mimica, who also stressed the traceability of products (our translation throughout).
At the current stage, two thorny issues are still dividing the member states. The first concerns the control procedure - should the regulatory system be based principally on measures prior to marketing, such as the control mechanism and certification by designated notified bodies, or should it also be based on more detailed arrangements that are stricter as regards after-trade monitoring (ex ante monitoring and ex post trade). Several member states have decided in favour of strengthening the role of the notified bodies and of increased monitoring of these bodies through better coordination between the member states and between the member states and the Commission, but they do not consider it necessary to set up a central monitoring mechanism for high-risk devices, which would lead to too much red tape that would be costly and damaging to the development of the market (especially Italy, Germany, Hungary, the UK, Luxembourg and Croatia). The second issue dividing opinion concerns the re-use of single use medical devices. Some member states are of the opinion that, for reasons of trade, manufacturers can market so-called single use devices, which are in fact perfectly re-usable - on condition that very strict rules are respected. This is the opinion of Belgium, Germany, the Netherlands and Luxembourg. Other countries, which are more numerous, are rather opposed to the re-use of these devices - such as Sweden, Finland, France, Italy, Poland, Bulgaria and Romania. Lastly, a majority of member states supports harmonised European rules - such as Spain, Latvia, Slovenia, Cyprus, Portugal, the Czech Republic, Malta, Estonia, Austria and Slovakia. This issue could nevertheless be settled by allowing member states to decide whether or not they want to authorise the withdrawal of single use devices and their trade (opt out). On this point, the Parliament decided that all single use devices could automatically be re-used.
During the Greek Presidency, detailed issues will need to be dealt with affecting ethics committees, notified bodies, patient safety and innovation, said the Lithuanian Presidency. Mimica is insisting on an agreement on the new framework under the Greek Presidency, before the European elections, believing that the issues that remain up in the air can be perfectly well settled under the current legislature. The Parliament is ready to begin interinstitutional negotiations after having given the mandate to the relevant rapporteurs following the plenary vote on the two reports last October, Mimica stated. “We will try to do a good job”, the Greek Presidency said, even if some member states - like the UK - think it unlikely that an agreement can still be found under this legislature. (IL/transl.fl)