All medical devices must bear the CE marking, which guarantees that the product complies with the essential requirements of all applicable European Directives. Obtaining the CE marking to market the product can be a challenge for both smaller companies in the sector and large manufacturers, due to the complexity of the Regulation, the involvement of a large number of actors and the lack of a single interlocutor.
Advice on CE marking of Class I medical devices.
We provide support for obtaining the CE marking of medical devices by identifying the Directives and/or Regulations applicable to the product, define the tests to be performed according to the applicable regulations to comply with the requirements and perform tests and offer support in the search for accredited laboratories if ITA is unable to perform some of the tests.
Product validation tests carried out at our facilities:
