Medical Devices

We provide consultancy services in the area of ​​medical devices (MD) and in vitro diagnostic medical devices (IVD), in accordance with Regulations (EU) 2017/745 and 2017/746.

We have experienced professionals to make it easier for manufacturers and distributors to comply with legal obligations, namely notification to the Competent Authorities of all types of DM and DIV.

We support manufacturers in preparing and organizing the technical documentation required for the conformity assessment process with a view to affixing the CE marking and preparing the CE Declaration of Conformity.

We prepare the documentation required to obtain the National Product Code (CNP), which will enable you to sell your DM in community pharmacies.

We can also provide medical device surveillance services, within the scope of the National Medical Device Surveillance System.