Supporting Medical Device Approval Submissions
Medical Devices and in-vitro diagnostics (IVD) registrations and submissions process vary drastically for every Health Authority. It’s important to note that the regulatory pathway for each submission type can be complex and may involve multiple stages.
Techsol provides expert guidance in compilation of all the required regulatory documentation such as the Technical File, Device Master File, Design Dossier and Design History File to help in faster reviews and approvals of medical devices.
Device Approval FDA Submissions
The FDA has established different types of medical device approval submissions, each with its own requirements and regulatory pathways. Our team can provide medical and regulatory expertise to complete the following types of device approval submissions:
This submission is for a medical device that is substantially equivalent to a device that is already legally marketed in the United States. This submission is intended for devices that are classified as Class II or Class III.
This submission is for a medical device that is considered to be a high-risk device and for which there is no legally marketed device of the same type. This submission is intended for devices that are classified as Class III.
This submission is for a medical device that is new and not substantially equivalent to a legally marketed device. The De Novo process provides a pathway to classify a low to moderate risk device.
This submission is for a medical device that is intended to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States per year. This submission is intended for devices that are classified as Class III.
This submission is for a medical device that is still in the investigational stage and not yet approved for marketing in the United States. The submission allows the device to be used in clinical trials to collect data on safety and effectiveness.
Device Approval EMA Submissions
With our expert regulatory knowledge on EMA requirements, we can support device manufacturers to complete the following device approval activities:
This is a mandatory marking for medical devices that indicates compliance with the essential requirements of the applicable EU directives. The CE marking is a self-declaration made by the manufacturer, and there is no formal approval process.
This is a centralised database for medical devices that is being established by the EMA. Manufacturers will need to register their devices in the EUDAMED database before they can be placed on the market in the EU.
This submission is for a medical device that is still in the investigational stage and not yet approved for marketing in the EU. The submission allows the device to be used in clinical trials to collect data on safety and effectiveness.
This submission is for a medical device that requires assessment by a third-party organisation known as a Notified Body. The Notified Body will review the technical documentation for the device and issue a certificate if the device is found to be in compliance with the applicable EU directives.
