Availability of medical devices – Survey (deadline 18 September)
On behalf of Elena Arbelo (EHRA Advocacy and Quality Improvement Committee Chairperson) and Jose Luis Merino (EHRA President), we would like to share the following message with you.
“Dear colleagues and friends,
The BioMed Alliance and ESC have supported the aim of the EU Medical Device Regulation (EU 2017/745) (MDR) which has applied since May 2021, to improve the standards of clinical evidence for high-risk medical devices.
Unfortunately, there are some unintended consequences including a chance that essential medical devices may disappear from the market. Contributory causes include the fact that that the personnel and resources that were envisaged to be needed in order to deliver the requirements of the new Regulation have insufficiently been allocated within the European Commission, and that the capacity of the notified bodies to approve devices remains insufficient. It is increasingly apparent that there is a real risk that many medical devices may be taken off the market by manufacturers and become unavailable for patients who require them, unless special measures are taken urgently to avoid this.
Medical device manufacturers reported from a recent survey, that 27% of all medical devices may be made obsolescent or discontinued (source MedTech Europe). Notified bodies announced that new certificates of approval have been issued for only 1069 devices out of a total of around 25,000 that need to be certified under the MDR (source MDCG1 meeting 19 May 2022). Medical devices for orphan or paediatric indications are particularly vulnerable to additional regulatory costs or delays, and although there is no European database to identify these products, the loss of even a small number of products can have major implications for health care across Europe.
With the survey below, the BioMed Alliance and ESC would like to assess whether if you have experienced or heard stories about the unavailability of medical devices due to them being taken off the market. We kindly ask you to disseminate it within your community and complete it by Sunday 18 September 2022.
As our field of clinical electrophysiology, cardiac pacing and defibrillation is particularly vulnerable to this is problem, we would kindly urge you to provide your feedback.
Thank you for your continuing support to our field and association”
Elena Arbelo José Luis Merino
EHRA Advocacy and Quality Improvement Committee Chairperson EHRA President