¿What are the consequences of marketing or publicly using a FITNESS Equipment that has not been approved under Directive 2001/95?


- Loss of all Civil Liability Insurance against injuries or accidents for putting in the market one appliance outside the law, just as a car insurance becomes null and void against third parties if the ITV is not updated.


 - Withdrawal from the market  and gym rooms, of the FITNESS, pilates, training equipment ,etc ... as a preventive measures to avoid public risks. This measure affects both manufacturers and distributors as well as owners of fitness , training and pilates rooms  (Akin to how a wine lote in poor condition is removed from a restaurant even if the manufacturer is another to guarantee the public health ) 


- In the case of manufacturers or distributors, the aggravation of the corresponding administrative sanction is added to the withdrawal from the market.


¿The so called "FITNESS Machines " are regulated by CE Marking and the Machine Directive 2006/42/CE?


Mostly no, for the next reason, Machine Directive 2006/42/CE , Article 2: 

 

Definitions:

 

For the purposes of this Directive, the term 'machine' refers to the products listed in Article 1, paragraph 1, letters a) to f).

The following definitions will apply:

 

"machine":

- set of interconnected parts or components, of which at least one is mobile, associated for a given application, provided or intended to be provided with a drive system other than human or animal strength,


Most of the FITNESS equipment are powered by human force , then are excluded from the machinery directive and for similar reasons from the rest of the CE marking sectorial Directives.


One exception is the Cardio Transport Sliding Platforms or similar equipments that have a motor connected to the network.. For this case is necessary the compliance of Machines Directive 2006/42 as well as  Directive on Safety of European Product  2001/95.


¿These FITNESS equipment are regulated by the Directive 2001/95 on Safety of European Products?


 Yes of course , because within the UE all the equipment and products must be safe as a precondition to allow the free movement of goods and people. The Directive 2001/95 covers by defect all the products and equipment in the absence of  a particular Sectorial Directive of CE-Marking.


¿ Has the European Comission developed the requisites of this Directive 2001/95 for the FITNESS equipment?


 Yes the European Commission has published two communications in which it deploys specifically the safety requirement of Directive 2001/95 in a list of essential requirements that any equipment of training and gymnasia, pilates included, must comply with for being put into the market and commercialized.


This communication are::


1º)  Commission Decision of  27 July 2011 DOCE  

L 196/16 On "Requisites for Equipment of Training" 

2º)  Commission Decision of 27 July 2011 DOCE  
L 197/13 On "Requisites fora Equipment of Gymnasia" 


¿These essential requirements published in the  European Commission Communications are mandatories?


 Yes, if these requirements are not fulfilled the equipment neither can be commercialized nor can be publicly used.


¿How the compliance with this essential requirements is proved and the manufacture-distributor provides evidence of it?

 

- Through the elaboration of a Technical File in which the manufacture document how he has verified and assured the compliance of the essential requirement of the European Commission for a prototype and by the issue of a Declaration of Conformity with the Directive 2001/95.


¿ What kind of Service FIDIAS provides?



           1.   Technical File elaboration with its corresponding certificate.


               2.       Elaboration and implementation of a Quality System to garantes the conformity of the serie with the  prototype verified.


               3.       Declaración of Conformity with Directive 2001/95.

 

==============================================

 PRESUPUESTO (TEL +34918644093 MOVIL +34625045552)


918644093 Móvil 625045552













QUOTATION (TEL +34918644093 MOVIL +34625045552)

 

918644093 Móvil 625045552

 

===================