+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Technical Dossier

The technical dossier is a collection of information and documents describing in details the medical device (MD), in vitro diagnostic (IVD) or the MD or IVD family under review and, in particular, those aspects related to the safety and efficacy of the product, from the design stage right through to post-marketing surveillance.

In general, the technical dossier should also include evidence of all solutions undertaken by the manufacturer to meet the general safety and performance requirements established by Regulations (EU) 2017/745 and 2017/746 in order to ensure the marketing of effective and safe products.

This collection of documents must be kept constantly up to date, and is subjected to the evaluation of a Notified Body in order to obtain (and maintain) the CE marking, an essential requirement for the marketing of MDs in the European market. The technical dossier is not evaluated by a Notified Body only in the following cases:

  • Class I medical devices
  • Custom-made medical devices
  • In vitro diagnostic medical devices complying with Directive 98/79/EC, unless they are self-testing devices or include in Annex II of the Directive
  • In vitro diagnostic medical devices in class A according to Regulation (EU) 2017/746

Once the MD/IVD is placed on the market, the national Competent Authorities have the right to inspect the technical dossier at any time, regardless their classification of the medical device. In addition, an incomplete or inadequate technical dossier may cause delays to market entry or a ban to release the product.

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for MDs and IVDs, and can therefore assist companies in all the steps of preparation of a technical dossier. In particular, Di Renzo Regulatory Affairs can:

  • support the manufacturer in the collection and submission of the documentation required
  • search and maintain relations with qualified testing laboratories
  • search and maintain relations with Notified Bodies
  • maintain relations with manufacturing sites
  • review all existing documentation supporting the compliance with the applicable requirements
  • identify applicable standards based on the type of product
  • identify tests/analyses to be performed on the device
  • support manufacturers in risk identification, evaluation and management
  • review/prepare labels and instructions for use
  • develop/update and implement a risk management process
  • draft, review and update the clinical evaluation plan and report, in accordance with the provisions in force and the European guidelines
  • assist in the post-market surveillance (PMS) activities, assuming the role of Surveillance and Vigilance Responsible Person, if necessary
  • design and create mock-ups for primary and secondary packaging

Foto di Myriams-Fotos da Pixabay