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Assigning of an European Union (EU) Authorized Representative by American and Canadian machinery manufacturers has been clarified.
Effective December 29/2009 all non-European based machinery manufacturers are required to identify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturer's technical file and to provide CE explanations in case of control.
The Authorized Representative must have received a written mandate (agreement) from the manufacturer before its name appears on the Declaration of Conformity along with the name and address of the manufacturer.
The term 'Authorized Representative does not describe a sales and marketing function, it describes a CE compliance/regulatory affairs function only.
The EU Commissions is strengthening its surveillance and enforcement of the CE mark program and requires that the first point of contact is the manufacturer's European Authorized Representative.
Release of a credible technical file should not be taken lightly since it contains confidential and proprietary/design information.
It is therefore of great importance to appoint an established and knowledgeable EU Authorized Representative firm, in accordance with an EU legal agreement that includes confidentiality.
ECM with offices in London (United Kingdom), is a professional EU Authorized Representative firm in accordance with
the Machinery, Medical and In-Vitro Diagnostic Directives, whose knowledgeable CE compliance managers have performed Authorized Representative services since 2000.
Effective December 29/2009 all non-European based machinery manufacturers are required to identify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturer's technical file and to provide CE explanations in case of control.
The Authorized Representative must have received a written mandate (agreement) from the manufacturer before its name appears on the Declaration of Conformity along with the name and address of the manufacturer.
The term 'Authorized Representative does not describe a sales and marketing function, it describes a CE compliance/regulatory affairs function only.
The EU Commissions is strengthening its surveillance and enforcement of the CE mark program and requires that the first point of contact is the manufacturer's European Authorized Representative.
Release of a credible technical file should not be taken lightly since it contains confidential and proprietary/design information.
It is therefore of great importance to appoint an established and knowledgeable EU Authorized Representative firm, in accordance with an EU legal agreement that includes confidentiality.
ECM with offices in London (United Kingdom), is a professional EU Authorized Representative firm in accordance with
the Machinery, Medical and In-Vitro Diagnostic Directives, whose knowledgeable CE compliance managers have performed Authorized Representative services since 2000.
