News New medtech regulations

Medical Device Industry Position on the Implementation of the New Medical Device Regulation

Posted on 19.12.2018

Providing products that work and are safe for patients is our utmost priority and at the core of what we do as a medical device industry.

Our industry is regulated, and we take our responsibility to comply with these regulations very seriously. Medical device manufacturers continue to support the new regulation and are investing heavily to comply with the new requirements.

Industry depends on the new regulatory system and its processes to be operational early and well before the implementation deadline to be able to re-certify today’s products against the new requirements on time. The industry’s ability to keep products on the market beyond the 26 May 2020 deadline could be seriously jeopardized by the slow progress in putting into place the critical infrastructure that will enable the new regulatory systems to work.

The medical device industry, through the voice of MedTech Europe, is not requesting more time to be ready.

The industry is ready to submit files for re-certification to maintain the supply of medical devices to patients and healthcare systems across Europe. However, to get this done, it needs Notified Bodies being in place early enough and with sufficient capacity to undergo the vast amount of re-certification procedures by May 2020. Without such re-certification, medical devices cannot continue to be made available to hospitals, healthcare professionals and patients. At this point in time, namely 17 months before the implementation deadline, not one Notified Body has obtained its re-designation to start this huge task. This remains industry’s highest concern.

Also, the new medical device regulation includes a ‘grace period’ mechanism. It allows for certain medical devices to be re-certified under the current medical devices directives with the certificates valid up to 2024. However, this ‘safeguard’ measure does not provide a system-wide solution and will not be able to solve the described re-certification bottleneck.
MedTech Europe underlines its call to authorities to provide timely solutions that will rapidly install the needed functionality of the new regulatory systems and in order to guarantee patients in Europe the continued provision of care that they experience today.