Medical device regulation challenges put children's surgeries at risk

Research led by Trinity College in Ireland has found that a regulation which came into effect in May 2021 with the aim of improving the oversight of medical devices in Ireland is leading to unintended consequences which may put some surgeries for children, and the treatment of rare diseases, at risk. The study has been published in the journal Pediatric Cardiology.

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 paediatric indications are particularly vulnerable to this.

The paper provides an example of one device, the Rashkind balloon catheter, first developed by Dr William Rashkind in 1966 to open the upper chambers in the heart in neonates with congenital heart disease. A number of these balloons were once available in Europe and now there is only one. This device may become unavailable next year. If this happens, it will not be possible to continue this procedure, and alternative surgeries or treatments are far less optimal. The paper also describes the timeline and cost of bringing the device to market in the EU, the US and Canada, and the cost and time needed to access the EU market has become much greater. 

Researchers believe there is now 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.

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Source: Trinity College Dublin, 20 October 2022