The European parliament voted today on the transitional provisions for certain medical devices (+537, -3, O24). Earlier in January, the Council of the European Union already accepted the proposed text of the European Commission. You can find the proposal through the following link: https://www.europarl.europa.eu/plenary/en/infos-details.html?id=922&type=priorityInfo.The Parliament approved the committee request, which means once the text is published in the European journal the extension of the transitional provisions is officially law. Devices with a valid CE certificate can make use of the transition period immediately.
Gert Bos: ''Great to see we all have a bit more time to reach the MDR certification; let’s use it wisely to improve our technical documentation, including collected and analyzed PMCF, and aim for first time right in the notified body conformity assessment!''
Giovanni Di Rienzo: "The extension of the transition period is encouraging news for the present and for the future as it shows that the EU system can be implemented with pragmatism when necessary. However, the MedTech sector should not take the foot off the accelerator, in particular keeping in mind the limitation to innovation for devices not yet fully certified with MDR"
Robert Paassen: ''Good news for patients in the European Union that medical devices will be kept available for the upcoming years. This gives manufacturers the chance to give a head start and update their Technical Documentations, gather all relevant data
and get their MDR CE mark. This extension period shouldn't be considered a time to take it slow: it is crucial to keep working so we do not find ourselves in the same predicament as we are in now in 5 years.'