Market access to Europe -  a Tutorial in seven steps.

(for electrical and electronic products)

Background

Free trade in Europe

Free trade can only exist when businesses can actually access each others markets. Being a promoter of open trade, the European Union wants to ensure that access to markets is facilitated for all.

Trade Union


The EC origins from the European Coal and Steel community (ECSC: 1951 ) and the European Economic Community (EEC: 1958). The EEC  has developed  a single market through standardised system of common laws.
Since the Maastricht treaty in 1993 the EEC is known as the European Union.
The EU policies ensure the free movement of goods and services and capital.

The ce-mark

For safety related goods a free market is obtained by application of the the ce-mark. By ce marking its product the manufacturer adn/or importer ensures the authorities that the product fulfils all requirements of all applicable legislation. These requirements have been laid down in product directives, European law, for the moment ensured by implementations in national law in all member states.

Step 1: Select the Applicable Directives

The Generic Product Safety directive
http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm

The GPSD aims at ensuring that only safe consumer products are sold in the EU. The GPSD is intended to ensure a high level of product safety throughout the EU for consumer products that are not covered by specific sector legislation (e.g. toys, chemicals, cosmetics, machinery). The Directive also complements the provisions of sector legislation which do not cover certain matters, for instance in relation to producers’ obligations and the authorities’ powers and tasks.
The directive is applicable to those product that have not been covered by another directive , such as  furniture, some machines, cosmetics and clothing. A publically accessible RAPEX system lists the EU notifications regarding decisions on unsafe products covered by this directive (and others).

For electrical and electronic equipment, the applicable directives are listed below.

The Low Voltage directive 2006/95/EC

Directive 2006/95/ECof the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to Electrical Equipment designed for use within certain voltage limits .
This directive ensures that equipment complying is safe to use in the intended environment for humans, pets and the environment and covers all health and safety risks, not exclusively those who are electric.
The directive is applicable to apparatus that at its input or output shows voltages between certain voltage limits.
Conformity assessment: No third party required and no notified bodies have been designated.

The EMC directive

The EMC directive (2004/108/EC) covers all electrical equipment that due to their design and application is capable of emitting electromagnetic energy, of be susceptible to electromagnetic energy in the range from 0 Hz to 400 GHz. That is virtually ALL equipment.
Conformity assessment: No third party required and no notified bodies have been designated.

The Radio and Terminal equipment directive

The R&TTE directive (99/5/EC) covers the safety of radio devices, such as remote car keys, but also you cellular and  fax at home. It includes all requirements of both te directives above and adds requirements for the efficient use of the spectrum.
Conformity assessment: No third party required and no notified bodies have been designated.

The Medical devices Directive

The MDD adds to ordinary equipment a range of extra requirements such as risk management, traceability and documentation quality. This is not a simple trajectory and a good consultant is needed.
Conformity assessment: Third party required and  notified bodies approval required for all but the simplest (Class I) devices.

Step 2: Select the Applicable test standards

A large number of standards have been designated under each directive for all kind of products. They are published for this purpose in the Official Journal of the EU on a regular basis and are called harmonized standards. It’s you job to define how and where your apparatus is to be used and thus which standards are applicable. However, we can help you.

Step 3: Obtain compliance

Obtain a presumption of conformity with the applicable directives mentioned under step 2 by applying the standards in step 3 in full, or select a TCF (Technical Construction File) route. In both cases you will need to provide:

Proof of Compliance

You will need test reports proving compliance with the selected standards or alternately proof that the equipment fulfils the essential requirements of the directives. For the MDD you additionally need approval from a Notified Body (unless Class I)

Step 4: make up your Declaration of Conformity

Manufacturers declaration

Make up the Declaration of Conformity, and list the proof of compliance you have made up under step3 and the directives and standards you selected under step 2 and step 3.

Step 6: Ce-marking

Adhere the ce mark to your product.

Step 7: Find a representative in Europe

Finding a REP

Find a Representative on EU soil that wants to sell your product and take responsibility for the compliance of your product