Introduction

As part of the commericialization of any medical device, you must determine where you wish to sell your product. Of course in the United States you must have Food & Drug Administration either clearance (Class II) or approval (Class III). In Europe, you must have a different approval. 

If you wish to sell your medical device in any of the following

<a href=http://europa.eu.int/index_en.htm European Union (EU)</a>countries - your medical device must have the appropriate “CE” marking.

Austria

Belguim

Denmark

Finland

France

Germany

Greece

Ireland

Italy

Luxembourg

The Netherlands

Portugal

Spain

Sweden

United Kingdom

Note: Switzerland is NOT a member

Compliance Consultants can “walk your device” through the entire process to achieve CE marking. We work with you interpreting the standard and outlining the requirements for obtaining the CE mark.

Technical File Preparation

As part of the CE requirements we prepare a Technical File (similar to the FDA required Device Master File) to outline the safety requirement of the product. Compliance Consultants creates this Technical File to meet the review of the third party certification.

Selection of Certifying Body

The CE Mark Certification requires a third party review of the Technical file to assure conformity to the appropriate standard. Compliance Consultants selects the most advantageous Certifying Body. We prepare the application and are present during the certification audit.

"Responsible Person" Assistance

As part of the CE mark requirements, a "Responsible Person" in European is required to be indicated in your Technical File and on your product's labeling. Compliance Consultants will function as your "Responsible Person", to maintain your Letter of Conformity, review all complaints, report events, and act as your liaison to the Notified Body and maintain your Technical Files

MDD - Medical Device Directive

This Directive outlines the requirements for putting the CE mark on medical devices for sale in the European Union. This Directive went into effect in June 1997. Compliance Consultants advises you as to the applicable portions of these requirements of the MDD for marketing medical devices in the European Union.

The MDD defines the device classification, the requirements of the Technical File (TF) and the need for an European address or an Authorized Representative (AR) in the EU.

Compliance Consultants will discover the classification of your device, prepare the Technical File and apply the CE mark on the product labeling as well presenenting you as the Authorized Representative.

Compliance Consultants will select the appropriate Certifying Body and submit your device for testing and certifying.

IVDD - In-Vitro Diagnostic Directive

This Directive outlines the requirements for applying the CE mark on In-Vitro Diagnostic medical products for sale into the European Union. This Directive becomes effective in October 2003. Manufacturers of IVDs are now allowed to place the CE mark on their products. Compliance Consultants will advise you how to comply with these requirements.

The IVDD defines the IVD classification, the requirements of the Technical File (TF) and the need for an European address or an Authorized Representative (AR) in the EU.

Compliance Consultants will classify your IVD, prepare the TF and apply the CE mark on your product labeling as well as obtaining the services of an AR. If your product requires review by a Certifying Body, Compliance Consultants will select the appropriate Certifying Body and submit your device for testing and certifying.