Decision Diagnostics Corp (DECN)

[IPwatcher]

Generally as long as it does no harm its good to go

IVDD Directive 98/79/EC, in particularly annex III is FAR more exacting than that!
But in any case, in what sense falsely advising someone infected with a potentially deadly and highly infectious disease that they are clear to go about their business, rather than isolating and seeking treatment could be construed as "doing no harm" is not entirely clear to me!

For FDA you have to prove efficacy.

Safety and Efficacy Most CERTAINLY are the requirements underpinning IVDD CE 98/79/EC requirements!

https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1998L0079:20090807:EN:PDF

Genviro will no doubt fall flat at Annex I (General requirements):

The devices must be designed and manufactured in such a way that,when used under the conditions and for the purposes intended, theywill not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons, or the safety of property. Any risks which may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety

Then there is annex III

The technical documentation must allow assessment of the conformity ofthe product with the requirements of the Directive. It must include inparticular:....

the test reports,
—adequate performance evaluation data showing the performances claimed by the manufacturer and supported by a reference measurement system (when available), with information on the reference methods, the reference materials, the known reference values, the accuracy and measurement units used; such data should originate from studies in a clinical or other appropriate environment or result from relevant biographical references,
—the labels and instructions for use,
—the results of stability studies.

There is a lot more stuff in there about QMS, documentation, ya da ya.... the full 9 yards in fact.
The Authorised agent has to be able to produce the full Device Design History file and test data, upon demand, to the Relevent National Authorities that actually enforce the harmonized standards.

If they can't and they are CE marking, its a bust!