Document paper New medtech regulations

The use of the single registration number – Proposal for an IVD Regulation

In their General Approach (Art. 23a), Council has proposed the use of a ‘Single Registration Number’ which would be assigned to each manufacturer or their authorised representative. Council envisions that the Single Registration Number (SRN) would be included in these areas: the device label, the EUDAMED database, the Unique Device Identification (UDI) data base, the summary of safety and performance, the declaration of conformity and certificates issued by notified bodies.

EDMA supports the concept of a Single Registration number, which will be helpful to identify and distinguish between manufacturers or their authorised representative.

It is, however, important that legislators choose the appropriate areas in which to require the use of the SRN. In most areas, the use of either the SRN or the UDI – but not both – should be required depending on its purpose. As an exception, because they are central and interlinked repositories of information, it is appropriate to include both the SRN and the UDI in the EUDAMED and UDI databases. The SRN should not be included on the device label because such a requirement would be both redundant and costly: all the information necessary to identify the manufacturer is already included on the label.

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Posted on 20.04.2016

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