The coordinators of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) decided on Tuesday 24 January to apply an urgency procedure (Rule 163 of the European Parliament’s Rules of Procedure) to the European Commission’s proposal for changes to EU legislation on medical devices and implantable devices.
The Commission had submitted a proposal on 6 January (see EUROPE 13094/1) to avoid a shortage of devices during the transition period to the new regulations EU/2017/745 and EU/2017/746.
On 25 January, the Member States’ ambassadors to the EU expressed their support for the European Commission’s original text, without modification (see EUROPE 13107/9).
Peter Liese MEP (EPP, German), the EPP coordinator for the ENVI committee, said on 26 January that it was possible that MEPs would adopt the text at the Parliament’s 13-16 February plenary session. Mr Liese believes that this must happen, as human lives are at stake.
The MEP had welcomed the Commission’s proposal, but wanted a long-term solution, especially for paediatric cardiology and surgery devices. In a plenary debate on 24 November 2022, he called for, among other things, a special regulation to provide incentives for paediatric medical devices, citing the example of a law in the United States. (Original version in French by Émilie Vanderhulst)