For Class IIa, IIb, and III Devices: Identify and engage a Notified Body accredited under the Medical Devices Regulation (MDR) or the Medical Devices Directive (MDD). Notified Bodies assess the conformity of higher-risk medical devices and issue CE certificates upon successful assessment.

Notified Body Fees: If your device requires assessment by a Notified Body (Class IIa, IIb, III under MDR), fees for conformity assessment can range from several thousand to tens of thousands of euros, depending on the complexity of the device and the scope of assessment required.

Device Classification: Determine the correct classification of your medical device (Class I, IIa, IIb, III) based on intended use and potential risks. This classification determines the conformity assessment route.

Identify Device Class: Determine the classification of your medical device according to the European Medical Devices Regulation (MDR) or Medical Devices Directive (MDD). Classes range from I (lowest risk) to III (highest risk), based on intended use and potential risks.

Legal Requirement: CE marking is mandatory for medical devices sold in the EEA. It indicates conformity with health, safety, and environmental protection standards set by European legislation.

Classification: Determine the correct classification of your medical device according to Annex VIII of the MDR or IVDR. Classification depends on the intended use, potential risks, and duration of contact with the body.

Obtaining FDA certification for a Class III medical device involves a comprehensive and often lengthy process due to the high-risk nature of these devices and the rigorous regulatory requirements. The timeline can vary significantly depending on several factors, including the complexity of the device, the completeness of the submission, the need for clinical data, and the FDA's review workload.

Annual Reporting: Manufacturers of Class III devices approved through the Premarket Approval (PMA) process are generally required to submit an annual report to the FDA. This report provides updates on device performance, adverse events, changes in manufacturing processes, and any new clinical data.