At their EU Council meeting in Luxembourg on Tuesday 16 June, European health ministers took note of a progress report by the Cyprus Presidency of the Council of the EU on the draft regulation submitted on 16 December by the European Commission (see EUROPE 13773/7) to simplify the rules applicable to medical devices and in vitro diagnostic medical devices.
The text seeks to address difficulties linked to the regulatory burden, which appears far too heavy, the lack of predictability of the regulatory framework for businesses, as well as the unavailability of certain medical devices.
Presenting the state of play, Cyprus’ Health Minister, Neophytos Charalambides, recalled that several Member States had asked for a reform as early as December 2024. In his view, the difficulties identified in the current framework undermine the attractiveness of the European Union for the development of these technologies and require rapid action by the co-legislators.
He also said that technical work had begun as early as March, once the language versions of the proposal became available, and that a first full reading of the text had already been completed.
The Cyprus Presidency noted that Member States supported the general objectives of the proposal despite several issues still remaining unresolved.
These include, in particular, the division of responsibilities, the proportionality of the requirements imposed on the parties concerned, the financial situation of notified bodies, the consistent application of the legislation and the adaptation of the regulatory framework to devices based on artificial intelligence and to cybersecurity issues.
Before the round table, European Commissioner for Health, Olivér Várhelyi, said that faster and more proportionate procedures were needed, that unnecessary administrative burdens had to be reduced and that scientific support for innovation had to be strengthened, particularly for medical devices based on artificial intelligence.
Several Member States supported continuing the work. Portugal welcomed the measures intended to promote innovation and strengthen scientific and technical support, while calling for clarification of the governance of the future regulatory system. For Greece, it would be essential to adopt an EU Council position swiftly in order to send a signal to the market and prevent supply shortages.
For its part, the Czech Republic, which supported the objectives of simplification and reduction of administrative burdens, asked for further details on certain new procedures, particularly regulatory sandboxes and the use of expert groups.
According to Germany, the reform should allow better access to innovative products, while guaranteeing patient safety and the supply of medical devices.
France, for its part, made anticipation of shortages a priority. It called for the introduction of a declaration of supply disruptions, together with mapping of Europe’s industrial base and the building up of stocks for devices considered ‘at risk’.
Ireland, which will soon take over the EU Council Presidency, pledged to move the file forward quickly. Lastly, the ministers took note of the progress report and handed over responsibility for the next stage of the work to the Irish Presidency.
Link to the draft regulation: https://aeur.eu/f/jzy ; and the annex: https://aeur.eu/f/jzz (Original version in French by Nithya Paquiry)