The technical dossier is a collection of information and documents that describe in detail the medical device under review and, in particular, aspects related to the safety and efficacy of the product, from the design stage right through to post-marketing surveillance. The technical dossier should also describe all possible solutions undertaken by the manufacturer to ensure the maximum safety of the device.
This document must be kept up to date and, with the exception of Class I medical devices, IVDs included in Annex II and auto diagnostic devices, should be submitted for assessment by a Notified Body in order to obtain the CE marking, a fundamental requirement for the commercialization of medical devices in the European market.
Once the medical device has been placed on the market, the competent national authorities have the right to inspect the technical dossier, regardless of the classification of the medical device, at any time. In addition, an incomplete or inadequate technical dossier may cause delays to market entry or the prohibition of the product release.
Di Renzo Regulatory Affairs assists many Italian and international companies in the certification process aimed at obtaining the CE marking. In particular, in order to obtain the CE marking, it deals with the compilation of the technical dossier and all the activities connected with it:
- Assist the manufacturer with the collection and production of the necessary documentation
- Maintaining relationships with analysis laboratories, the Notified Bodies and any production sites
- Review all existing documentation in support of compliance with the applicable essential requirements of the Directive
- Identify applicable standards based on the type of product
- Identify tests / analyzes to be performed on the medical device
- Assist the manufacturer in the identification and assessment of risks
- Review / prepare labels and instructions for use
- Develop / update and implement a risk management plan
- Draft the clinical evaluation in accordance with the European guidelines
- Design and create mock-ups for primary and secondary packaging