The company is already oriented towards MDR 2017/745 EU (new regulation on medical devices, in force in the next year) in regulatory process and in customer relations such as Own Brand Label procedure.
Esoform - Certifications
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Certification CE
Complies with the requirements of MDD 93/42/EEC & s.a.s. Medical Devices Directive.
The company obtained EC certification in 1995, the first in Italy for Medical Devices Directive.
