EU policymakers must implement regulatory changes targeted at devices for pediatric and rase diseases to prevent essential products from becoming unavailable to EU patients, 23 clinical organizations say in an open letter penned to the EU commissioner for health and food safety.
The European Academy of Paediatrics (EAP), along with 22 clinical associations, are calling on the European Commission to take urgent policy actions to prevent the loss of medical devices used in pediatric or orphan disease patients caused by medtech regulatory pressures in the region.
The implementation of the Medical Device Regulation has “unintentionally resulted in increased time and costs for manufacturers,” the clinical associations say in a 27 June letter addressed directly to Stella...
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
