The Opportunity

Eunice Healthcare with its experience in the clinical laboratory and research markets, will introduce your products to the European laboratory market.

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 Authorized 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 provide you with the outlets 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.

The EDMA (European Diagnostic Manufacturers’ Association) 2006 Report has evaluated the total IVD market in Europe at over $9 billion.  Moreover, an ageing populations and the ever-increasing demand for state-of-the-art medical care has ensured a continuing, annual growth of over 5% in the European IVD market in recent years. EDMA 2006 data (PDF) show particularly strong growth in the areas of testing associated with cardiac markers and diabetes.

The Obstacles

European countries display an amazing multiplicity of approaches in the area of healthcare. The IVD markets in the various countries are fragmented between public and private sectors, by medical traditions, and not least, by reimbursement policies.

With the application of the IVD Directive in December 2003, the European Union (EU) has mandated that all IVD devices for use in the human clinical setting must be registered and have the CE-mark affixed.  Each EU country and certain other states (e.g., Switzerland) have mandated the languages that are acceptable for the IVD product labeling in that country.  

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

The Solution

Eunice Healthcare provides you with solutions for both the regulatory and commercial aspects of bringing your products successfully to the European market. 

As your Authorized Representative, Eunice Healthcare will:

• Ensure your quality system and files meet the essential requirements of the IVD Directive
• Insure the translation of product labeling into appropriate languages
• Interact with the relevant Notified Body for Annex II products ((PDF document; 80K)
• Register products with the appropriate Competent Authority (link to web site)
• Maintain files for inspection when requested by the Competent Authority
• Perform post-market vigilance
• Advise on changing regulatory requirements

As your Commercial Representative, Eunice Healthcare will:

• Appoint distributors
• Organize product training
• Co-ordinate orders
• Arrange logistics
• Manage receivables

To explore your needs for entering the European market, please contact us for a discussion on how Eunice Healthcare can help you succeed in Europe.