TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 116

To: Customers purchasing Selectrol strains

It is our intention to change the Instructions for Use of the Selectrol range of products. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately

Product: Selectrol

Product codes: All MM codes

Proposed Change Date: 1 July 2023 (or sooner if current IFU stocks run out)

Change Details:

Selectrol Instructions For Use (IFU) will change to a format that meets IVDR requirements. The IFU supplied in the clamshell pack with the Selectrol vial(s) will be in English only. Electronic versions of the IFU (eIFU) translated into all EU languages will be available on our website
https://www.tcsbiosciences.co.uk/qcerts/.

Reason for Change:

TCS continues to work towards meeting the requirements of the In Vitro Diagnostics Medical Device Regulation (IVDR) in accordance with the timeline for Class B devices. The IFU has been updated to include additional details (IVDR Annex II).

Considerations:

There is no change to the intended use of Selectrol. There is no change to the way in which Selectrol discs are to be removed from the vial or used on solid / liquid media by the end user. The IFU contains additional details including 'in use stability' and 'serious incident reporting'.

Conclusion:

The changes to the IFU have been made to meet the IVDR requirements. The IFU has been translated into all the languages of the EU and the translations are available electronically.

For more information on TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 116 talk to TCS Biosciences Ltd