Medical Devices

Program

Medical Devices – Technical Documentation

Medical Devices – Guidelines for Preparing a Technical Documentation

Workshop and materials will be in English language.

Regulation (EU) 2017/745 on Medical Devices (MDR) also deals with the preparation of a technical documentation to demonstrate conformity of a medical device. Changes relate mainly to the manner and complexity of presenting evidence of compliance of a medical device. A technical documentation has gained in importance in the process of demonstrating compliance, and its preparation is of focal importance. The content and complexity are determined by various factors, especially the classification, intended use, type of a device, specific properties of the product, method of production, etc.

Purpose

Participants get familiar with the requirements relating to medical devices and the current legislation, as well as with the requirements for the conformity of medical devices. Based on practical examples, the participants get to know the tools for identifying the need for compliance of a device with harmonized standards, which directly affects the structure and content of the technical documentation. Based on the acquired knowledge and the consideration of practical examples, the participants prepare a short study – a draft technical documentation for a medical device.

 Content

  • Basic overview of MDR requirements relating to technical documentation
  • Supporting documents, guidelines (MEDDEV, GHTF and similar)
  • Structure of a medical device technical documentation
  • Classification of medical devices
  • Risk management (EN ISO 14971)
  • Applicability (EN 62366)
  • Biological evaluation (ISO 10993)
  • Sterilization
  • Clinical evaluation of a medical device
  • Labelling and instructions for use of a medical device
  • Construction and implementation documentation
  • Declaration of conformity
  • Classification of medical devices
  • Use of harmonized standards and cases of incorrect application of standards
  • Preparation of risk assessment documentation
  • Making a clinical evaluation
  • Creating a usability record
  • Making a record of biological evaluation
  • Preparation of model instructions for use
  • Preparation of a declaration of conformity
  • Frequent mistakes and identified good practices of economic operators

Preparation of a technical documentation

After the first two meetings, the participants prepare a short, focused study – a draft technical documentation for a medical device, which they present to the group in the third part of the workshop and exchange good practices.

Lecturer

Matija Rupnik has been active in the field of medical devices, their development and related legislation since the beginning of his career. He has participated in the establishment of quality systems in accordance with international legislation and in ensuring the compliance of active medical devices. For manufacturers, he performed the tasks of integrating quality management systems, determining regulatory strategies, and ensuring the compliance of medical devices, including the production and maintenance of medical device technical documentation. He is currently the head of regulatory matters at one of the manufacturers and an SIQ auditor.

Who should attend?

All of you in charge of developing medical devices.

Quality managers in development and production companies.

Agents, trademark holders, distributors, and importers of non-European medical devices.