Due to their impact on human life, medical devices are highly regulated. Not only that, but the list of products in scope of medical device regulation...
Mitigating the Damage Caused By Supply Chain Disruptions During The Coronavirus Outbreak
The personal toll of the COVID-19 (coronavirus) outbreak is mounting, with nearly 100,000 reported cases and over 2,800 deaths. However the impact on ...
EU MDR Three Months Out: A Checklist
For medical device companies in the European Union (EU), the May 26, 2020, application date for the EU Medical Device Regulation (MDR) looms large on ...
The Scope of the EU Medical Device Regulation
The European Union (EU) Medical Device Regulation (MDR) is due to take full effect in May 2020, and its new scope includes a large number of products ...
EU MDR Replaces Medical Devices Directive, Prompting More Stringent Requirements for Medical Device Companies
The European Union (EU) Medical Device Regulation (MDR) EU 2017/745 replaced the Medical Devices Directive (MDD) on May 25, 2017, with the aim of impr...
Medical Devices Under Greater Food & Drug Administration Scrutiny
Between 2009 and 2018, the U.S. Congress and the U.S. Food and Drug Administration (FDA) enacted a number of laws designed to improve the efficiency a...
Environmental Protection Agency to Evaluate 40 Substances Under the Toxic Substances Control Act
On March 20, 2019, the U.S. Environmental Protection Agency (EPA) outlined 40 substances to undergo the evaluation and prioritization process outlined...
European Union Commission Requests Feedback on Regulatory Impacts
The European Union Commission is collecting feedback about restrictions on hazardous substances in electrical/electronic equipment (EEE) via an online...
New Proposition 65 Labeling Requirements Now in Effect
Changes to the California Safe Drinking Water and Toxic Enforcement Act (better known as Proposition 65) officially came into effect today. Products n...
ECHA Investigates After Proposed Microplastics Ban
Products ranging from glitter hair gel to living room paint could be affected by a European Chemicals Agency (ECHA) investigation into the use of micr...