What is CE Marking and Technical File?
CE marking is an important procedure that guarantees a product’s conformity to EU regulations. Numerous products require CE marking before they can be sold in the EU. It demonstrates that a product has been evaluated by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anyplace in the world that are then marketed in the EU/EAA markets.
The purpose of a technical file is to demonstrate that your product conforms to the applicable and current medical device regulations.
The technical documentation includes various types of information related to the design, manufacture, and CE conformity of the product.
Prior to entry into the US marketplace, many medical devices require premarket submissions so FDA can evaluate the safety and efficacy characteristics of the device.
There are several different types of premarket submissions. The most common types of premarket submissions include:
- 510(k) (Premarket Notification)
- PMA (Premarket Approval)
- De Novo Classification Request.
- HDE (Humanitarian Device Exemption)
QC Analytics can help you to determine the appropriate regulatory pathway for your device, including cases where premarket submissions are not required.