Decision Diagnostics Corp (DECN)

[Luka Brasi]

Posted on YMB

CE Mark requirements review/facts: A GenViro! 'in vitro diagnostic medical device' is not on any of the lists located in Annex II to Directive 98/79/EC, therefore no involvement of a Notified Body is necessary unless for self-testing. Also, therefore, no third-party conformity assessment is required, and there is no govt body approval required. DECN (manufacturer with no EEA office) must: draw up the declaration of conformity (DoC) to declare his sole responsibility for the conformity to the relevant EU directive; designate a single authorised representative in the European Economical Area (EEA).