New rules for placing electrical apparatus on the market
Since 20 April 2016, electrical apparatus of all kinds has had to comply with requirements which are harmonised in Switzerland and Europe. With the entry into force of the new European regulations and the amendment of the Ordinance on Electromagnetic Compatibility (OEMC), the obligation on the manufacturer and whoever places apparatus on the market to provide information is extended.
From the entry into force of the OEMC, all electrical apparatus placed on the market in Switzerland must carry a conformity mark. It must also bear the address of the manufacturer of the product, not just their name. Furthermore, the information must be written in a manner which is understandable to users and always in the official language of the location where the product is put on sale as a minimum.
For the conformity mark, the manufacturer may choose between a Swiss mark or its European equivalent.
The manufacturer must, however, ensure coherence between the affixed mark and the indications in the declaration of conformity. If the Swiss mark is used, the documentation must refer to the Swiss legislation (OEMC; CC 734.5) and to the EU harmonisation legislation (EMC Directive; 2015/30/EU) if the product bears the EU conformity mark.
In order to assess the conformity of apparatus, the manufacturer has still the choice between two procedures, both under its own responsibility. It may carry out an internal production control procedure, in the same way as before. It may also have the apparatus type examined by an independent body. It then receives a type examination certificate if the technical documentation which it supplied to the conformity body proves that the essential requirements are met. It must then indicate the name of the institution which carried out the analysis in its declaration of conformity. If a certificate is refused, the other conformity assessment bodies are informed to prevent a manufacturer from submitting the same product to the other conformity assessment bodies.
Furthermore, from now on the declaration of conformity must refer to all the legislation which relates to the product and which requires a declaration of conformity. A dossier comprising several declarations of conformity is also regarded as a single declaration of conformity.
The procedure also provides for a follow-up obligation. On the one hand, the manufacturer must inform the conformity assessment body of any change made to the product. On the other hand, the body must notify any repercussion on technological evolution in the technical standards or in the harmonised standards which might involve re-assessment of the product's conformity.
If it does not wish to follow this procedure, the manufacturer can nevertheless carry out an internal manufacturing inspection itself. In this case the modalities remain unchanged.
Whatever its choice in relation to establishing the declaration of conformity, the apparatus manufacturer must from now on supplement the technical documentation with an analysis and an assessment of the risks relating to electromagnetic compatibility. CENELEC (the European Committee for Electrotechnical Standardisation) has developed harmonised standards which simplify this analysis and assessment.
The essential requirements concerning electromagnetic compatibility (EMC) have not changed: items of electrical apparatus may not cause interference and must have a specific immunity to interference. Consequently, the technical standards developed by CENELEC (also termed harmonised standards in the EU) under the old legislation and published by OFCOM continue to assume a presumption of conformity with the essential requirements when they are applied.
The new legislation identifies four economic operators: the manufacturer, the authorised representative, the importer and the distributor. It assigns different responsibilities to each of these operators. Primarily it is up to the manufacturer to guarantee the conformity of the products which it places on the market. It may delegate some but not all functions to an authorised representative. The importer must ensure that the manufacturer has in fact fulfilled all the obligations which enable it to place its equipment on the market. Finally, the distributor must also ensure that certain points are fulfilled.
All the economic operators must be able to identify their preceding and/or subsequent counterpart in the chain. Moreover, they are obliged to collaborate with OFCOM within the framework of market surveillance and to take measure themselves if they have reason to believe that the product which they are placing on the market is not in conformity.
Products which were placed on the market before 20 April 2016 may continue to be marketed in Switzerland, since the new legislation applies only to equipment placed on the market after this date.
An EU guide on the application of the EMC Directive (2014/30/EU) will soon be available. With regard to the basic framework for the marketing of products, the "Blue Guide" issued by the EU gives more details.
