European countries have many approaches but there is one common factor in the area of healthcare -  the need to have CE-marking on in vitro diagnostic (IVD) products. The European Union’s IVD Directive (applied in December 2003) mandates that all IVD devices used in the human, clinical setting must be registered and have a CE-symbol affixed.

It is also a requirement that non-EU IVD manufacturers that do not have an establishment or affiliate in Europe must appoint an Authorised Representative who is domiciled in the European Union.

These regulations do not apply to reagents used in an evaluation or research setting.

Eunice Healthcare will ensure that your quality system meets the requirements of the IVD Directive, will register your products and will help you find the approriate distribution channels to sell your products.

The markets in Europe are fragmented between public and private sectors, by medical traditions and by reimbursement and funding policies. This is where the experience and local knowledge of Eunice Healthcare will ensure the success of your products in Europe.