Regulatory Diagnosis and Preparation of a Plan for Placing Medical Devices on the Market

The placing on the European market of Medical Devices is subject to compliance with the requirements of European Community legislation, namely:

  • Regulation (EU) 2017/745 – on medical devices

  • Regulation (EU) 2017/746 – on in vitro diagnostic medical devices

This service aims to carry out the legal framework of the product, namely in Regulation (EU) 2017/745 or Regulation (EU) 2017/746, and other reference documents such as harmonized standards and MEDDEVs. This work will produce a framework report.

The activities needed to be implemented for compliance with regulations 2017/745 and 2017/746 will be identified. As a result, an implementation plan will be made with all the necessary steps to bring the device to the European market.

As far as possible, budgeting or estimation of the costs associated with each stage will be carried out.

This proposal includes the following steps:

  • Device identification and “intended purpose.”

  • Compliance with applicable Directives or Regulations.

  • Identification of applicable harmonized standards.

  • Planning and budgeting for:

    • Assessment of essential safety and performance requirements.
    • (Pre-) Clinical evaluation.

    • ISO 14971 risk assessment.
    • Preparation of labeling and instructions for use.

    • Establish a post-marketing monitoring system.
    • Preparation of the EC declaration of conformity.
    • Preparation of the technical file.
    • Review of the technical file by the Notified Body.
    • Implementation of the quality management system following ISO 13485 and respective certification (if applicable).
    • Eudamed registration.