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Commercializzazione Dispositivi Medici

Medical device marketing and post-marketing

Obtaining the CE marking allows the marketing of medical devices all over the EU. However, after the marketing, and for the whole life cycle of a product, manufacturers should carry out post-marketing activities, so that the concerned MDs and IVDs can continue to comply with the applicable regulations and the CE marking is duly applied.

Moreover, there can be specific national requirements to be considered, in order to be able to market the products.

The main services offered by Di Renzo Regulatory Affairs in this field are:

  • registration of manufacturers, authorised representatives, MDs and IVDs at the Italian Ministry of Health and Competent Authorities of the other EU Member States
  • registration of manufacturers, importers, authorised representatives and assemblers in the EUDAMED’s module regarding economic operators to obtain the single registration number (SRN)
  • post-marketing surveillance activities (PMS) according to the requirements of the current Directives and Regulation (EU) 2017/745 (MDR)
  • devicevigilance activities, taking on the role of vigilance responsible person
  • taking on the role of Person Responsible for Regulatory Compliance (PRRN) on behalf of manufacturers and authorised representatives
  • advice to companies acting as authorised representative (e.g. contacts with EU competent authorities, product notification, incident reporting etc.)
  • check/revision of labelling and IFUs/manuals in case of marketing in a new State
  • targeted advice on real issues related to the device sale/distribution
  • advice on regulatory procedures for import/export activities
  • requests of free sale certificates (FSC)
  • medical device promotion

Foto di HeungSoon da Pixabay