To: Customers purchasing Stain HD products
It is our intention to change the IVD status of the products listed below. 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: StainHD products as specified below
Product codes: Product codes prefixed HS and HDS. HC6405 Periodic acid (1% aqueous)
Proposed Change Date: 26 May 2022
Change Details:
Products with codes as listed above will no longer be CE marked but will carry the UKCA mark.
From this date StainHD products will be available for UK sale, but no longer available for sale in the EU.
Reason for Change:
The products listed in this change control are currently CE marked in accordance with the IVD Directive.
These products will carry the UKCA mark in accordance with the UK Medical Devices Regulations 2002 (SI 2002 No. 618) as amended, for in-vitro diagnostic medical devices from 26 May.
The CE mark will be removed from these products from 26 May.
Considerations:
From 26 May 2022 Regulation 2017/746 the EU IVDR will come into force in the EU. This regulation will not apply to the UK. TCS Biosciences has taken the commercial decision not to transition the StainHD product range to IVDR, therefore the CE mark will be removed from these products and they will not be available for sale in the EU.
From 26 May 2022 IVD registration of the StainHD products with product codes listed above in Great Britain will be in accordance with the UK Medical Devices Regulations 2002 and thus the product labels will carry the UKCA mark.
Conclusion
The changes listed above have no effect on the formulation and quality of the StainHD products included in this change control.
May 2022
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