Our Services

Device Classification

Using our unique, intelligent Classification Chart, we offer our members the ability to classify their medical devices in a way previously unheard of. The chart utilises knowledge of the classification rules according to Annex 9 from Council Directive (93/42/EEC) to determine what EC Product Class your medical device belongs to. Once you complete the classification of your device, a Classification Report will be available for your device which you can download as PDF. Saving you time and effort, CLASSify will quickly become your primary resource when classification or re-classification is necessary.


Classify your device now!


You will need to become a member before you can use this service. Information on registering can be found on our registration page.


Users of CLASSify should note the following:


* Only European Community legislation printed in the paper edition of the Official Journal of the European Union is deemed authentic.


* The letters CE stand for "Conformité Européenne" which means "European Conformity". "CE marking" is now used in all official EU documents. The CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer. The CE marking affixed to products is a declaration by the person responsible that the product conforms to all applicable Community provisions and that the appropriate conformity assessment procedures have been completed.


For further guidance, consult http://ec.europa.eu/enterprise/faq/ce-mark.htm and the following links http://europa.eu/abouteuropa/faq/index_en.htm and http://eur-lex.europa.eu/en/tools/help_syntax.htm


CE Mark of Conformity

Product Database

This section allows members to view details on medical devices which have been listed either by CLASSify or by other companies. Details logged about the product include its contact mode and duration, CE number, as well as its 510k and PMA numbers. A valuable resource for competitors or one for promotion – whichever way you look at it, it allows you to view information on products which would otherwise take valuable time to source.


View the CLASSify Product Database.

Subscriptions

CLASSify will soon be offering subscriptions for use of the CLASSify Chart. If you are interested, please contact us via email.

Other Services

CLASSify is part of Adveniunt Medical International Limited and is a sister company of Quality First International (QFI). QFI is a medical device consultancy company, providing a range of focused, medical device oriented services and offering an EU Authroised Representative Programme, a Microbiology Advisory Programme as well as others which you may find useful. Please visit www.qualityfirstint.com for more information.