Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation
Posted on 02.05.2019
On the 15th of April, MedTech Europe sent an open letter on the MDR to Mr. Jyrki Katainen, Vice-President for Jobs, Growth, Investment and Competitiveness at the European Commission. In this letter, the medical device industry in Europe confirms that without immediate action by the European Commission, the new regulatory system will not be ready on time to ensure continued access of patients and healthcare systems to life-saving and life-transforming devices.
One of the critical concerns of the industry is the designation and capacity of Notified Bodies, which the European Commission and Member States are still assessing to the new rules. The industry has urged Mr. Katainen to address this situation and safeguard the continuity of patient care in the region and the sustainability of an SME-driven medical device industry.