For diagnostic laboratories in the European Union
The WID®-easy test as IVDR Article 5 (5) test
The regulatory basis
Healthcare facilities, such as diagnostic laboratories, have the possibility to manufacture and use the WID®-easy tests in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) Chapter II, Article 5 (5)or corresponding national regulations.
The necessary scientific and technical information can be found in the published literature, in particular Evans et al, The Lancet Oncology, 2023.
Clarifications and comments
In January 2023, the Medical Device Coordination Group (MDCG) published the“Guidance on the health institution exemption under Article 5 (5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746“, which clarifies and comments on key aspects of the regulatory basis.
The WID®-easy PCR kit
Application
Diagnostic laboratories can obtain all necessary reagents for the production and use of the test from relevant suppliers.
To simplify logistics, healthcare facilities can obtain a set of reagents required to carry out the PCR reaction from Sola Diagnostics GmbH as an RUO PCR kit (“WID®-easy PCR Kit”).
The legal manufacturer of the RUO WID®-easy PCR Kit is Sola Diagnostics GmbH. The PCR kit was verified and manufactured in collaboration with BIOTYPE GmbH in Dresden (Germany). BIOTYPE has been a renowned German solution provider for precision molecular diagnostics, contract development and production for 25 years. BIOTYPE is certified according to the standards DIN EN ISO 13485 and DIN EN ISO 9001 in the area of sales, development, production and services of molecular biological tests for in-vitro diagnostics (ISO 13485:2016) and for research and diagnostics (ISO 9001:2015).
Sola Diagnostics GmbH provides the WID®-easy PCR Kit to health institutions at a cost price with no profit margin.
IFU - Instructions for Use
The WID®-easy PCR Kit IFU – Instructions for Use – can be downloaded from the following link.
Safety data sheet
The WID®-easy PCR Kit safety data sheet can be downloaded from the following link.
Quality assurance
Certificates of analysis
CoA - Batch Code: SOLA-0002
CoA - Batch Code: SOLA-0003
CoA - Batch Code: SOLA-0004
For diagnostic laboratories in Great Britain
The WID®-easy test as an in vitro diagnostic (IVD) with UKCA labeling
The regulatory basis
The WID®-easy PCR Kit as an in vitro diagnostic (IVD) fulfills the requirements of the UK Medical Device Regulation.
IFU - Instructions for Use
The WID®-easy PCR Kit IFU – Instructions for Use – for the UK market in accordance with the requirements of the UK Medical Devices Regulations can be downloaded from the following link.
Safety data sheet
The WID®-easy PCR Kit Safety Data Sheet for the UK market in accordance with the requirements of the UK Medical Devices Regulation can be downloaded from the following link.
Quality assurance
Certificates of analysis
CoA - Batch Code: SOLA-0005
Intellectual property rights
The performance and marketing of the WID®-easy test are subject to the intellectual property rights of University College London (“UCL”) and Sola Diagnostics GmbH.
“WID” is a registered trademark of Sola Diagnostics GmbH.
The rights to perform and market the WID®-easy test can be acquired from Sola Diagnostics GmbH as a license or sublicense (in the case of UCL rights). The licensing fee is calculated based on the number of reports billed by the health institution.