Portland Oregon, EU Directives & CE Marking Services Company & Consultant
The European market comprises 27 countries, 500+ million people and 20+ different languages. Few US companies should bypass this lucrative market. The EU legislation is sophisticated. Our summary:
- The CE mark is a product certificate that allows manufacturers worldwide to place their products on the European market.
- EU directives define the CE mark. EU directives are approved by the European Union and are transcribed into the national laws of the EU member states, who become responsible to enforce them.
- Many directives define Essential Requirements (ERs) to be met by a product. Compliance with harmonized standards (standards published by the EU in its Official Journal) provides presumption of compliance to the ERs and simplifies access to the market.
- Depending on product risk classification, as defined in the directive, the manufacturer may self-certify the product, or needs to invoke the services of a Notified Body. Multiple conformity assessment routes may exist and it is up to the manufacturer to decide which allowed route it will take.
- A major difference with the FDA is the “State of the Art” principle. It requires that devices placed on the market are state of the art. When “State of the Art” changes, (as for instance expressed by a new or changed harmonized standard), any product to be placed on the market has to be brought in compliance with that standard. The transition period is defined in the European Journal.
- Major benefits can be obtained by intelligent grouping of devices into product families with shared characteristics.
Placing on the market
A non-EU manufacturer (Manufacturer: Entity who places the product on the market under its own name, not necessarily the entity who manufactures the product) who wants to place his products on the EU market must in many cases appoint an Authorized Representative (AR) located in the EU.
AR tasks are defined in some directives and include communication with the EU and cooperating with the EU on behalf of the manufacturer in case of (potential) health or safety issues. A copy of the technical construction file must be available to the EU through the AR.
A non-EU manufacturer has the following options for appointing its AR
1. Assign (one of) its European subsidiary/office
2. Assign (one of) its EU based dealers / distributors
3. Contract with an EU based independent 3rd party AR
Important services that must be contracted with an AR:
1. Notify manufacturer of changes in EU legislation, standards etc
2. Inform authorities of placement of product on the market
3. Representing the manufacturer and coordination between EU regulatory authorities and the manufacturer in case of major (potential) incidents
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