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The CE marking, according to the class of the device can be issued by a Notified Body, for MD of any class higher than I, or be issued in self-certification, by the manufacturer itself, for the devices of class I.
In order to demonstrate the conformity of its products with the requirements of Directive DM 93/42 / EEC and subsequent amendments and in the near future to the new Medical Device Regulation 745/2017, the manufacturer must in any case draw up a technical dossier to be kept at the disposal of the Competent Authority and to be submitted to the Notified Body, if the device is of a class higher than I.
The services that Maytal can provide to support the MD manufacturers for drafting technical documentation are:

• Risk analysis
• Clinical validation
• Validation of the product software
• Validation of usability
• Biocompatibility
• EU MDR classification, identification of standards and applicable tests
• Drafting of the technical documentation

Since Maytal consultants are experts in the sector, the services listed above can be provided by supporting the manufacturer from the early stages of the project, by outlining the correct directions for designers towards regulatory compliance.

Some countries of the European Community require that devices placed on the market in their territory, even if CE marked, are registered in their territory. This requirement is imposed in order to allow adequate market surveillance and to be able to sell to the public health facilities of the country im question.
Maytal can support you in the process of registration with the competent ministries of the following countries:

• Italy
• Spain
• Belgium