New guidance documents for EMDN and cybersecurity

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The European Commission has issued new guidance documents on the new nomenclature system EMDN that manufacturers must use under the Medical Devices and IVD Medical Devices Regulation (EU) 2017/745 and 2017/746 (MDR and IVDR).

The EMDN system will base on the Italian CND nomenclature system. The corresponding codes will be used – among others – for the registration process in EUDAMED. In this context, the Commission has also issued an explanation and overview of the CND system.

Both documents may provide initial details about the nomenclature system under the MDR and IVDR. 

In addition, the Medical Device Coordination Group (MDCG) issued a guidance document on cybersecurity. The MDR and IVDR require manufacturers to “develop and manufacture their products in accordance with the state of the art taking into account the principles of risk management, including information security, as well as to set out minimum requirements concerning IT security measures, including protection against unauthorised access.”

A strong advice from us

The present guidance document is intended to help manufacturers to comply with the corresponding requirements. It is strongly advised to review the document.

Source: MDCG guidance documents

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