Medical Devices


The complex reviewing process of European Regulation regarding medical devices lead to the EU Regulation 2017/745 on May 2017, with full application from 26 May 2020.

The new regulation sets very articulate dispositions, clearly defining roles and specific responsibilities of various participants in the production chain. There are numerous variations regarding classification rules (especially for medical devices based on substancesRule 21), compliance evaluation procedures, post marketing surveillance instructions, requirements for clinical data evaluation, identification and traceability tools for medical devices.

The new regulation force companies to identify, within personnel, a person responsible for regulatory compliance who has to be competent in the medical device area. Micro and small enterprises shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

In such a complex frame of news, SAPORITI CONSULTING supports companies on marketing new medical devices, re-classifying procedures according to the new regulation and as person responsible for regulatory compliance, offering:

  • medical device formulation development
  • market research aimed to find innovative ingredients and packaging
  • shelf-life evaluation and definition
  • efficacy and security test evaluation and definition in partnership with accredited laboratory
  • person responsible for regulatory compliance (Art.15 Reg. 2017/745) with consultancy contract
  • new product classification and re-classification of existing products
  • borderline products evaluation
  • drafting and review of labelling and package leaflet complying with European regulation
  • readability criteria evaluation and definition
  • technical dossier drafting consultancy
  • notified body contact and CE marking of conformity consultancy
  • stability studies definition
  • in-process quality control procedures and finished product quality control procedures definition
  • contact with a network of accredited laboratory of analysis
  • GMP and ISO certification consultancy
  • support during audit for Italian and foreign companies