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As a French SME operating in the medical device sector, we welcome the European Commissions initiative to simplify and streamline the EU regulatory framework for medical devices. We urgently call for measures to reduce administrative burden, enhance predictability, and foster innovation and competitiveness, while maintaining the highest standards of patient safety.

MedTech Europe welcomes legislative reform, provided it delivers a regulatory system that enhances competitiveness, is efficient, lean and fit for purpose, supports innovation, is well-governed and ensures patients access to devices. Short-term relief measures are needed in parallel to the reform (e.g.

MedTech Europe welcomes the opportunity to provide feedback to the European Commissions proposal around the targeted reform of EU rules on medical devices (MD) and in vitro diagnostic medical devices (IVD). Europes regulatory framework for medical technologies is at a decisive moment.

This proposal is needed and is a good news,but 2 aspects need to be reviewed : Article 1(1), point (a), of the proposal extension of the validity of certificates : In some third parties' countries it is required to have certificates with valid dates it is critical for the business to have NB re-editing the Certificates with the extended dates Article 1(1), point (b), of the proposal extension of the transition…

MedTech Europe takes note of the European Commissions proposal to amend the transitional measures in the Medical Devices Regulation (EU) 2017/745 and welcomes its recognition of the ongoing urgent risks of medical device shortages in Europe stemming from the Regulation implementation challenges.