European Commission Releases Further Harmonised Standards under EU MDR

The New Year saw the European Commission (EC) publish a second batch of harmonised standards under the EU MDR. Commission Implementing Decision (EU) 2022/6, released on 4 January 2022, amends the earlier Implementing Decision (EU) 2021/1182 published in July 2021. It introduces a further nine harmonised standards that medical device manufacturers should reference to satisfy conformity requirements under the MDR.

FDA Issues COVID-19 Transition Plans for EUA and Enforcement Actions

Following the declaration by DHS of the COVID-19 Pandemic, the FDA began to issue Emergency Use Authorization (EUA) approvals and enforcement policies for devices used to mitigate the spread of the SAR-CoV-2 virus, including the diagnosis, treatment or prevention of Coronavirus Disease (COVID-19). On, December 23, 2021, the Agency acknowledged the general need for a transition process back to ‘normal operations’ and released two draft guidance documents that introduce their proposed transition plans.

FDA Releases 3D Printing at the Point of Care Discussion Paper

FDA Announces Release of “Playbook for Threat Modeling Medical Devices”

NAMSA Expands Minneapolis Preclinical Laboratory to Meet Industry Demand for Medtech Research and Development Solutions

NAMSA, the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today the expansion of its Minneapolis preclinical research laboratory. This expansion will add 55,000 sq. ft. to the current 130,000 sq. ft. preclinical campus in Minneapolis.