Technical documentation is a fundamental requirement under the European Union Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746). It provides evidence that a Medical...

CE Marking is a mandatory regulatory requirement for Medical Devices marketed in the European Union (EU) and European Economic Area (EEA). It confirms that a device meets necessary safety standards, health, and...

MHRA is the UK’s official regulatory body that oversees medicines, vaccines, and Medical Devices to ensure they meet strict standards of safety, quality, and effectiveness. It evaluates products before approval, monitors them...

IFU requirements (EU MDR) define what a Medical Device instructions leaflet must contain to ensure safe and correct usage of the Device. An IFU must contain all essential safety details, technical guidance,...

GDUFA self-identification is a mandatory FDA compliance process for generic Drug facilities and related sites. It supports FDA self-identification (Generic Drugs) by mandating structured annual submissions. The process ensures transparency, supports regulatory...

The National Drug Code or NDC system works as a structured method for identifying Drug products in the United States. It describes the format, assignment process, and regulatory requirements for companies that...

A US Agent is a mandatory requirement for foreign Medical Device manufacturers exporting to the United States under US agent FDA requirement guidelines. The agent serves as a regulatory communication link between...

Manufacturers outside the United Kingdom must appoint a UK Responsible Person (UKRP) to place Medical Devices on the Great Britain market. The UKRP acts as the manufacturer’s regulatory representative and primary contact...