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 ...

Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification.

The US Food and Drug Administration (FDA) has released a new guidance document finalizing its recommendations for the medical device industry on how to use Classification Product Codes (CPC), a ...

The Global Harmonization Task Force issued a guidance that provides 17 rules for device classification, according to a MassDevice report. The guidance provides rules for classification of devices and ...