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Medical Device

EC Directive 93/42 relative to medical devices came into force on 1st January 1995 and became mandatory on 16th June 1998.

Only those devices having the following characteristics can be marketed:
they satisfy the essential requirements of the Directive;
the products and/or the company has been approved by a notified body (with the exception of Class I products);
they bear the CE marking followed by identification number of the notified body (with the exception of Class I products).

         

The Directive divides the products into four classes, depending on the hazard level of the device. The classification parameters are given in Annex IX to the Directive. For each class, the Directive describes the possible procedures for the attestation of conformity to the essential requirements. In particular:
for Class I products, the manufacturer can affix the CE marking after having made a Declaration of Conformity to the essential

requirements;

for Classes IIa, IIb and III, the intervention of a notified body is required.

The manufacturer can choose among product certification (type certification + lot tests), full company quality system certification, or a mixed system (type + production or product quality system certification).

 

 

 

 

 

   
 
Electrical Products
In line with its traditional activities, UTC offers several services to companies.
PPE Protective Equipment
UTC, as a certification&testing center, can fulfil the procedure for the certification
Construction Products
The Directive 89/106/EEC, Construction Products Directive enacted iby Presidential...
Machinery
UTC is a certification body for conducting procedures of conformity assessment .
 
UTC Product Service Ltd.
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