The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...

NQA reports that the EU MDR classifies medical devices into four risk categories, outlining compliance requirements and the ...

In summary, the CJEU’s decision clarifies that distributors must act with due care based on available information but are not responsible ...

The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are ...

As technology advances and medical devices become an increasingly integral part of healthcare, understanding the regulatory pathways for medical devices is critical for many biotechnology companies ...

The intended use of medical device software will dictate its regulatory path, and engineering teams should be aware of such ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...

Embedded development for medical devices is a job where the weight of "building according to established procedures and ...