IVD UKCA-marking for the WID?-easy Test

On 20 December 2024, Sola Diagnostics reached another important milestone in the rollout of the WID?-easy test, an epigenetic PCR test for the non-invasive detection of endometrial cancer.

The WID?-easy PCR Test Kit received market authorization for Great Britain by registering the device at MHRA ("Medicines and Healthcare products Regulatory Agency") and confirming that the WID?-easy PCR Kit, manufactured by Sola Diagnostics GmbH, meets all applicable regulatory requirements under the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

Product Details:

• Product Name: WID-easy PCR Kit
• Product Type: In-Vitro Diagnostic (IVD) kit
• GMDN Code: 59010 (Methylated DNA IVD, kit, nucleic acid technique (NAT))

Regulatory Compliance:

The WID-easy PCR Kit is self-certified under Part IV of the UK MDR 2002, Annex III Sections 1-5 (as modified by Part III of Schedule 2A to the UK MDR 2002).

The following harmonised standards and technical specifications have been applied:

1. EN ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes
2. EN ISO 14971:2019 - Medical devices - Application of risk management to medical devices
3. ISO 15223-1:2021 - Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
4. ISO 18113-1:2022 - In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
5. ISO 18113-3:2022 - In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use.

The WID-easy PCR-Kit thus fulfils all the necessary safety and performance standards.

Instructions for Use

WID?-easy PCR Kit Manual UKCA marked (EN)