MedTech Europe welcomes Parliament’s vote to revise MDR

Article summary

MedTech Europe has welcomed the European Parliament’s vote on the joint motion for a resolution on the urgent need to revise Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)), which calls for measures to be adopted to address key challenges and bottlenecks in the implementation of the MDR. The organisation also stated it supports the Parliament’s call for the European Commission to propose a systematic revision of all relevant articles of the MDR and Regulation (EU) 2017/746 the In Vitro Diagnostic Medical Devices Regulation (IVDR)) as soon as possible. MedTech has emphasised that reducing and making predictable initial assessment timelines and costs, making assessments of changes to medical technologies more efficient, and adapting certification timelines to follow a life-cycle approach is key for making devices available to patients.