Brussels, 19/06/2015 (Agence Europe) - Three years and six Presidencies after the European Commission tabled its proposal, the Health Council finally agreed, in Luxembourg on Friday 19 June, on a partial general approach on medical devices and in vitro diagnostic medical devices.
The compromise tabled by the Latvian Presidency was not entirely satisfactory to all delegations, but all member states agreed that it was high time to start moving forward to improve an obsolete and inadequate framework, whilst the European Parliament, which agreed on its position over a year ago, is ready and waiting. “Perfect is often the enemy of good enough. The text on the table is a balanced compromise, which is not satisfactory to all delegations, but (…) we mustn't open Pandora's box by adding further modifications at this stage”, said the Latvian health minister, Guntis Belevics. Congratulating the Latvian Presidency on “its remarkable efforts to reach an acceptable compromise on such a complex dossier”, the Commissioner for Health, Vytenis Andriukaitis, said that the technical discussions had gone on for long enough and that what was now needed was the political will to take it forward. “Thank you for responding to the urgency of the situation (…). This is an excellent basis to negotiate with the EP”, stressed the Commissioner, who is well aware that general interests won the day in the talks.
The agreement is still only a partial one, as it does not take account of the recitals and the technical details still need a bit of work. It is now the job of the preparatory bodies of the Council to discuss the recitals and refine the text to remove any inconsistencies, so that a full general approach can be achieved under the Luxembourg Presidency, which will make it possible to conclude the dialogue with the European Parliament. At this stage, there are still questions to be sorted out regarding the assessment process, the reprocessing of single-use devices, aesthetic and cosmetic medical devices and the single identification system for medical devices.
During the debate, some of the delegations stressed the points they wish to return to in greater depth at a later date, to be resolved during the inter-institutional discussions. For instance, several member states still have concerns over: - the cost of the procedures (Slovenia, Poland, Denmark and the Czech Republic); - the pre-marketing control mechanism (France, United Kingdom, Greece and Bulgaria); - the reprocessing of single-use devices (there are some issues outstanding for Greece and Portugal, whilst Poland and Romania are completely opposed); - aesthetic devices (Denmark argues that specifications need to be attached, whilst Romania still has some issues over traceability). Austria also has a few questions over the transparency of clinical trials and takes the view that an agency along the same lines as the European Medicines Agency needs to be set up for medical devices.
Medical devices cover an enormous range of products (contact lenses, heart valves, dental fillings, etc.). They are sorted into three categories, from the lowest risk level (Category 1) to the highest (Category 3). Similarly, there is a huge range of in vitro diagnostic medical devices, such as blood tests and other products to provide information about a patient's state of health. Unlike medicines, these devices are not actually subject to testing before they are placed on the market, but must undergo a compliance assessment involving a notified body, depending on the potential risk of the product. These independent bodies are appointed and supervised by the member states.
The European Commission presented its revision of the legislative provisions on medical devices and in vitro diagnostic medical devices in the midst of considerable outrage in 2012, in the wake of the PIP faulty breast implants scandal (see EUROPE 10697). The new legislation is designed to improve protection for patients and consumers through a rigourous assessment of the characteristics of the devices in terms of safety and efficiency before they are placed on the market, together with radically reinforced control procedures. Healthcare professionals will be better informed of the benefits to patients, residual risks and the overall risk/benefit ratio and manufacturers will have clearer rules to follow, with trade facilitated between countries of the EU and fair conditions of competition, shutting out operators not acting within the law.
In a departure from the Commission's proposals, the Council recommends stepping up the pre-marketing rules with regard to appointing notified bodies and for the supervision of their activities by the competent national authorities. As regards post-marketing controls, the Commission added specific proposals regarding the manufacturers' liability. (Isabelle Lamberty)