Legal Overview Of MDR’s ‘Overly Broad And Vague Article 10a’

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.

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.