TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 81

To: Customers and Distributors of animal blood and serum products

It is our intention to change the status of the products listed below. The details of the change and the reason for it are given below.

Product: Animal Blood and Serum products – see Appendix 1 for full list of products and product codes

Proposed Change Date: 1 January 2022

Change Details:

These products will no longer be classed as in vitro diagnostic products (IVDs). The labels for these products will not include the CE or IVD symbols.

Reason for Change:

Currently the products listed in Appendix 1 are classified as IVDs in accordance with Annex Ill of Directive 98/79/EC and a self-declaration of conformity is available for each product.

Directive 98/79/EC is to be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) for which the date of application is 26 May 2022.

It is a requirement of the IVDR to reclassify all IVDs in accordance with the classification rules. None of the seven classification rules applies to the animal blood and serum products listed in Appendix 1.

As the animal blood and serum products are used as raw materials in manufacture and not as finished products for in vitro diagnosis of patients it will also not be possible to meet all the IVDR requirements for conformity assessment and performance evaluation.

For these reasons the products in Appendix 1, below, will no longer be classed as IVDs.

Considerations

The removal of the CE and IVD symbols will have no impact on the manufacturing processes or quality of the products listed in Appendix 1; the change described is solely the removal of IVD status.

These products will continue to be suitable as raw materials for manufacture of IVDs.

TCS Biosciences will retain and maintain the ISO 9001:2015 quality management system, ISO 14001:2015 environmental management system and !SIA (International Serum Industry Association) Traceability Certification in accordance with current practices.

There is no impact on the issue of certificates of analysis for the products listed in Appendix 1.

APPENDIX 1:

Dec 2021