Tested began as a Research project looking at the detection of SARS-CoV-2 in *** via qPCR using a hypecube pooling method. We would like to become an accredited facility offering Covid-Testing to the University. However our method is not CE Marked and potentially need to apply for derogation. Is this something you have encountered before and can provide advise on how to go about this.
Secondly any advise on what is required for Stage 1 Declaration Application.
However our method is not CE Marked and potentially need to apply for derogation. Is this something you have encountered before and can provide advise on how to go about this.
I cannot tell, based on your comments, if your Quantitative Polymerase Chain Reaction (qPCR) is laboratory-based or point-of-care. For molecular point-of-care COVID-19 Tests, the accreditation body will have specific requirements.
Regarding the CE marking, I assume you are referring to the kit you use for your test. A CE conformity marking is applicable to goods not a method. A CE-IVD mark is required for regulatory approval for a product for in vitro diagnostic use in Europe and other areas. I advise you to contact your accreditation body to determine if this impacts on your accreditation.
You also asked
Secondly any advise on what is required for Stage 1 Declaration Application."
Application for COVID testing accreditation as a private provider is government and accreditation body specific. The minimum standards depends on the type or purpose of test. This will be available from the Accreditation body’s website.
Stage 1 Declaration Application typically involves a declaration stating that your tests meet the appropriate standard, and that you have at least applied for accreditation for relevant international standard. That would be ISO/IEC 17025 or ISO 15189 for lab-based providers and ISO 15189 and ISO 22870 for point of care testing providers.