Orphan Medical Devices and Pediatric Cardiology - What Interventionists in Europe Need to Know, and What Needs to be Done.

Abstract

Medical devices include a great diversity of technologies, which are evaluated and approved in the European Union (EU) according to a revised law that came into effect on 26 May 2021, known as the Medical Device Regulation or MDR (EU 745/2017). It has a transition period that allows products that were approved under the previous rules (the EU Medical Device Directives) to continue to be marketed until 26 May 2024 at the latest. As a result of a series of unforeseen factors, there is a possibility that the MDR may result in products becoming unavailable, with the consequent risk of a loss of some interventions that are reliant upon those devices. Devices that are used for orphan or pediatric indications are particularly vulnerable to this. There is an urgent need for policy to be developed to protect essential medical devices for orphan indications and for use in children, to ensure that necessary interventions can continue, and to ensure a more sustainable system in Europe over the longer term. Pediatric cardiologists in Europe need to be aware that particular medical devices may become unavailable over the next two years, and they should contribute to plans to mitigate this risk, so that they can continue to deliver the best possible care for their patients. This commentary examines the factors which have contributed to this issue and suggests ways that policy can be developed to address it.Article title: Kindly check and confirm the edit made in the title.Title is okay