Device Description: Detailed specifications, intended use, and design features.

Determine the correct classification of your medical device according to the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). This determines the conformity assessment route.

Notified Body Fees: If your device requires the involvement of a Notified Body (typically for Class IIa, IIb, III devices and some IVDs), fees can range significantly. These fees cover the conformity assessment activities, including document review, audits, and testing. Costs can range from several thousand to tens of thousands of euros, depending on the complexity and scope of assessment required.

Device Classification: Determine the correct classification of your medical device according to the MDR or IVDR. This classification determines the conformity assessment route and requirements.

Device Classification: Determine the classification of your medical device according to the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Classification is based on the intended use, potential risks, and duration of contact with the human body.

Classification of Your Device: Determine the classification of your medical device according to EU regulations (Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR)). This classification will dictate the conformity assessment route and requirements.

EU Authorized RepresentativeAn EU Authorized Representative is an institution or a natural person who represents a non-EU manufacturer within the EU. They are charged with ensuring that manufacturers comply with EU regulations and communicating and coordinating with EU regulators, customers and other stakeholders.

The difference between medical device classification levelsMedical devices have different classification levels in the domestic market to distinguish their risk levels and management requirements. These classification levels are called mechanical font sizes, including mechanical Ⅰ, mechanical Ⅱ and mechanical Ⅲ. Understanding the differences between these machine font sizes is critical for manufacturers, regulators and consumers alike. The following will introduce the differences between Machine I, Machine II and Machine III.