Edition of 26 July 2023

On 27 June 2023, a group of 23 European associations delivered an open letter to Commissioner Kyriakides of the European Commission, calling for stronger action to protect access to essential medical devices for children and people living with rare diseases in light of the ongoing implementation of the EU Medical Device Regulation 745/2017 (EU MDR). The letter was authored by the European Academy of Paediatrics, and co-signed by a number of rare disease organisations, including ERICA, IRDiRC, and the ERNs ERKNet and eUROGEN.

The EU MDR was introduced in 2017 in order to improve the evaluation and safety of high-risk medical devices to better protect patients. However, as it has become implemented, concerns have been raised about the increased financial and time costs it has imposed on manufacturers. This harms profitability, and disincentivises companies from making devices available for low-prevalence conditions as it is impossible to recover the regulatory costs incurred.

In the letter, a number of policy actions are recommended in order to maintain the availability of medical devices for paediatric and rare diseases. In particular, the signatories call for the European Commission and European Parliament to:

• Correct the unintended consequences of the EU MDR to ensure continued access to essential medical devices for children and patients with rare diseases;
• Establish an EU-wide monitoring system to track devices that may disappear or have disappeared from the market;
• Delegate the assignment of “paediatric device” or “orphan device” status to an EU Expert Panel with competent paediatric experts;
• Expedite the conformity assessment process for high-risk devices with paediatric or orphan device status, involving clinical and paediatric expertise, and implementing a capped maximum fee to incentivise the introduction of devices for small patient groups;
• Establish transition solutions to maintain device availability until the above changes have been implemented.

Overall, the aim of these actions is not to undermine the EU MDR’s original goal of protecting patients by strengthening clinical evaluation and safety of high-risk medical devices, but to ensure that it is pursued in a manner which ensures medical devices remain available and affordable for those who need them most.

A new article has been published in BMC Geriatrics which explores how people affected by rare dementias were impacted by lockdown measures during the COVID-19 pandemic. In particular, researchers investigated the effects of the first lockdown on people living with familial Alzheimer’s disease, behavioural variant frontotemporal demential, familial frontotemporal dementia, dementia with Lewy bodies, posterior cortical atrophy, and primary progressive aphasia in the UK and their carers. Through a mixed method study, participants were asked about their self-reported strategies for coping, and key issues and themes were identified using framework analysis.

It was found that during lockdown, many people with dementia experienced a deterioration of their condition. This was observed through negative impacts on things like speech and language abilities, mood, behavior, social interaction, and support. Carers also reported negative impacts on their own mental health due to reductions in the support they received. Exacerbating these impacts was a general sense of losing time to the restrictions, given the progressive nature of dementias.

Despite the significant challenges observed, researchers were also able to identify coping strategies which participants found effective for dealing with the challenges they experienced. These findings could help inform the development of better tailored support for people living with rare dementias and their carers in the case of future health emergencies.