Regulations

Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical device development and post-market activities.

A deep dive into how COVID-19 has forced many healthcare providers to adopt telehealth solutions, and some legal considerations for manufacturers.

Class I medical device companies have work to do, despite the UDI enforcement delay.

Manufacturers, authorized representatives, importers, and distributors will have added responsibilities under the EU MDR. Are you prepared?

With the death of Supreme Court Justice Ruth Bader Ginsburg, legal scholars see an increased chance that the Affordable Care Act is overturned. What will this mean for medtech?