The role of Non-European Manufacturers

If you are a medical device manufacturer located outside the European Union or the European Free Trade Association and wish to export into the European Market, you must follow several steps to ensure that your product is in compliance with the European Directives.

This article is intended to provide you with a general understanding of your responsibility as a manufacturer. However, we recommend that you contact Obelis (O.E.A.R.C.) to walk you through these specific and detailed steps. The following Products require Non-European Manufacturers to appoint a European Authorized Representative:

The following are steps you must take to prepare your product for sale within Europe:

• Appoint Obelis (O.E.A.R.C.) as your European Authorized Representative within the EU Territory. In order to apply for CE marking, you must appoint a “European Authorized Representative”, which means a person established within the European Community or in a State which is Party to an Association Agreement who, explicitly designated by the manufacturer, act for the manufacturer and may be addressed by the authorities and bodies in the Community instead of the manufacturer. Obelis (O.E.A.R.C.) provides superior quality European Authorized Representative Services, click here for details.
• Assess your product according to the essential requirements in the Directives.(directive library).
• Identify the appropriate conformity assessment module according to your product classification. (MDD modules or IVD route).
• Prepare a product Technical File, including a product user manual, as outlined in the Directive Annex below.
• Determine the applicable Standards - European, International or National (applicable standard link).
Labeling & Instruction of use MDD 93/42/ECC Article 4.4 MDD 93/42/ECC Annex I § 13.3 IVD 98/79/EC Annex I § 8
• If required, choose a Notified Body to perform the official conformity assessments tasks in accordance with procedures in the Directives. (MDD Notified Bodies, IVD Notified Bodies). A Notified Body plays an important role in the procedure for obtaining a CE marking for devices in classes IIa, IIb and III and for class I products placed on the market in sterile condition and/or with a measuring function. The notified body is a certification organization designated by the national authority of any EC country, which is authorized to conduct conformity assessments in accordance with the procedures in the directive. The notified body offers its services to the manufacturer with the aim to have the manufacturer’s product put on the European market in conformity with the directives. The notified body performs its activities in a competent, neutral, independent and non-discriminatory manner. The European Commission assigned an identification number to each designated notified body.
• The management will create a “vendor’s endorsement”.

Technical File must include:

1. A general description of the product.
2. Design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc. with explanations.
3. The results of the risk analysis.
4. The results of the design calculations and of the inspections carried out, etc.
5. The test reports and, where appropriate, clinical data.
6. The label and instructions for the use.

It is important to note that this is only a partial list; there will be more requirements depending on which class your product falls into.

• For selected types of devices, the European Authorized Representative must notify the product to the Competent Authorities(MDD class 1 and all IVD products)
• Determine the proper Labeling method based on applicable directives.

• Assemble the required approvals and certificates and prepare an EC Declaration of Conformity per product according to the applicable Directives.

• Affix the CE Marking in accordance with the European Directives.
• The Manufacturer /European Authorized Representative must make the technical documentation, including the declaration of conformity, available to the European Authorities for inspection purposes, for at least five to ten years after the last product has been manufactured
• The manufacturer must institute and keep up-to-date systematic procedures to review the experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking into account the nature and risks in relation to the product.

• The manufacturer must also immediately notify the European Competent Authorities (via the European Authorized Representative) of the following incidents:
• • Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in their state of health;
  • Any technical or medical reason connected with the characteristics on the performance of a device for the reasons referred in the Directive leading to systematic recall of devices of the same type by the manufacturer.

Note: If a ce approved product causes any of these incidences OUTSIDE the European Union, you must report such incidents to the European Authorities (via the European Authorized Representative).
Obelis (O.E.A.R.C.) provides superior quality “European Authorized Representative Services” with fully integrated business solutions to assist you in your venture to Europe and/or the United States. Obelis (O.E.A.R.C.) is backed by 16 years giving Commercial, Regulatory, Administrative, and Market development services.

Last updated Dec 28, 2008

Contact us now to find out more.

View all Publications