After the technical documentation has been compiled and the EU Authorization Representative has been appointed (if required), the manufacturer may start the registration process. This process:
- is for all risk classes of medical devices and IVDs in the EU Markets
- Should be completed before the appointment of the Notified Body for assessment of conformity assessment procedure, as applicable.
Step1 : Basic UDI-DI and UDIs Issuing Entities (designated by the EU Commission ) such as IFA GmbH, GS1 AISBL, Health Industry Business Communications Council, and ICCBA give the basic UDI-DI and UDIs respectively.
Step2 : Registration of EU Representatives, Manufacturers and Importers
- Economic operators must register themselves in the Actor Registration Module where information regarding them and their device must be entered.
- After verification of the information entered, the Authority will issue (to Economic Operators) an SRN (Single Registration Number) from the Electronic system.
- This SRN can be used by manufacturer for applying to notified body for conformity assessment.
Step3 : Registration of Devices
In the device registration modules, basic UDI-DI is entered followed by other information related to the medical device (like quantity per package, name, address of manufacturer and SRN, and member state information. For low-risk Medical devices and In Vitro Diagnostics, followed by the registration process, As per guidelines, the EU Declaration of Conformity needs to be prepared for the market launch. For high-risk Medical devices, the notified body‘s involvement is essential for conformity assessments. The manufacturer should prepare the EU declaration of conformity (upon the audit approval for CE Marking ) for market launch.
If you need guidance specially crafted for your medical device, then you can contact us with your query. Our team of experienced regulatory experts will help you in increasing market access to your products in the European Market.