CYduct Diagnostics Inc (CYDX)

[FatFox]

In order to sell a medical device or IVD within Europe, a CE Mark must be on the product. The CE Mark is not a quality certification nor is it intended for consumers. It is used by the European Competent Authorities (National Ministries of Health) as a way to determine whether the product has met the requirements of the Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC or the Active Implantable Medical Device Directive 90/385/EEC.

The Medical Device Directive states that companies must:

Compile a Technical File with evidence of compliance to the Medical Device Directive (or the IVD/AIMD Directives)

Receive a CE Mark (CE Marking) certificate from a Notified Body if medium or high risk device

$$$ Appoint an Authorized Representative$$$ if no physical office in Europe

Register medical devices with the Competent Authorities
Once these requirements are met the CE Mark may be used.

Since we are all posting one link or another. This is from expert resource web site. The only thing I see holding this up is hashing out the details about the authorizes REP. A partnership is inevitable if they plan to sell overseas. Exclusive or non-exclusive.