Medmarc Blog (blog.medmarc.com)
Medical Device Manufacturers (6)
EU releases IVD Risk Classification Framework
The medical device regulatory office for the European Commission (EC) finalized a guidance for risk categorization of in vitro diagnostics (IVDs), but concerns about the related implementation...
HHS Announces Delayed HIT Compliance Deadlines
The Department of Health and Human Services has responded to concerns about compliance dates for healthcare IT with an interim final rule that relaxes those deadlines by nearly half a year....
An Overview of Liability Immunity for Products Meant to Counter COVID-19 Under the PREP Act
Device manufacturers (as well as drug manufacturers, distributors, and health care providers) are struggling to answer many questions regarding their potential products liability in responding...
Pandemics and Force-Majeure Clauses
With the Coronavirus (COVID-19) pandemic, medical device companies are facing disruptions to their supply chains, vendors who simply stop providing services, and a denuded work force. Who is...