Eco-design of Medical Devices
Dernière mise à jour : 25/06/2026
Description
In a context where environmental responsibility, regulatory compliance and sustainable innovation are becoming major drivers for medical device manufacturers and designers, integrating eco-design from the earliest stages of product development is now essential.
This intensive two-day training provides a comprehensive and operational approach to eco-design applied to medical devices, based on the NF X30-264 and ISO 14006 standard. It combines theoretical input, real-life case studies, collaborative workshops and practical tools to help participants understand how to identify environmental levers compatible with regulatory requirements (MDR, ISO 13485), assess real gains and communicate responsibly. This pragmatic approach equips professionals with the skills to structure and promote a relevant eco-design strategy adapted to the constraints of the medical sector.
This intensive two-day training provides a comprehensive and operational approach to eco-design applied to medical devices, based on the NF X30-264 and ISO 14006 standard. It combines theoretical input, real-life case studies, collaborative workshops and practical tools to help participants understand how to identify environmental levers compatible with regulatory requirements (MDR, ISO 13485), assess real gains and communicate responsibly. This pragmatic approach equips professionals with the skills to structure and promote a relevant eco-design strategy adapted to the constraints of the medical sector.
Domaine : Dispositifs Médicaux
Objectifs de la formation
- Understand the regulatory framework, the norms and challenges of eco-design applied to medical devices (NF X30-264, ISO 14006, ISO 13485, ISO 14971, MDR, ISO 14021).
- Structure and manage an eco-design approach for the development or optimization of a medical device.
- Identify and develop suitable eco-design technical solutions for medical devices.
- Learn how to assess and validate environmental gains of an eco-designed system.
- Understand how to build a sustainable integration and communication strategy.
- Integrate eco-design throughout the medical device life cycle.
- Eco-design with monitoring and continuous improvement.
Public visé
Medical device project managers, RA/QA, R&D managers, eco-design specialists, industrial designers, regulatory affairs professionals, medical device development consultants.
All audiences (MD / IVD industry).
All audiences (MD / IVD industry).
Prérequis
No prerequisites
Programme
- Introduction to Eco-Design / Applicable Frameworks
- Key definitions: eco-design, life cycle, LCA, system
- Regulatory overview (AGEC law, ESPR, PPWR…) and sustainable public procurement in France
- Principes & steps to implement ecodesign based on the norms NF X30-264 & ISO 14006
- Environmental challenges associated with medical devices (MDs) along its life cycle
- Benefits of eco-design
- Overview of other applicable standards and reference frameworks (ISO 13485, ISO 14971).
- Framing a Medical Device Eco-Design Project
- Context analysis
- Analysis of the level of maturity of your company in terms of ecodesign and definition of the ambition of the ecodesign project
- Environmental Impact Analysis of an MD
- Selection of the appropriate “system” (MD, packaging, healthcare system) and the Functional Unit (FU) for a medical device: method, pitfalls, examples
- Presentation of the main environmental Indicators in a Life Cycle Assessment (LCA)
- Presentation of the tools to analyse environmental impact
- Exercise : analyse your MD with the Index DM Durable, tool used by the purchasing department of public hospitals in France
- Researching and Designing an Eco-Designed Solution
- Presentation of Environment-oriented innovation methodology
- Ecodesign guidelines for MDs
- Multi-criteria decision methods (environment, cost, regulation, use)
- Practical workshop on a real case
- Assessing, Validating and Testing Gains
- Check of potential rebound effects and impact transfers
- Creating an eco-design solution validation sheet and its link with the validation file
- Communicating on the Ecodesign Approach without greenwashing
- Relevant claims (ISO 14021, NF X30-264)
- Types of communication: internal / client / authority
- Examples of admissible claims vs. greenwashing
- Capitalization, Integration into QMS and PDCA
- Compatibility with Design Control process (FDA / MDR), integration into QMS ISO 13485 (document control, management review, design review)
- Basics of a medical device eco-performance dashboard
- Link with the continuous improvement loop (PDCA) and with risk management (ISO 14971)
- The first steps to implement your ecodesign project
- Finding subsidies
- Define a roadmap
- Conclusion and Questions
- Summary of the session and Q&A session
- Resources to deepen knowledge
- Evaluation MCQ
Modalités pédagogiques
This two-day programme is designed to provide a comprehensive introduction to eco-design of medical devices. Sessions are structured to encourage interactive discussions and hands-on exercises to ensure thorough understanding of the concepts presented.
Moyens et supports pédagogiques
Modules structured with objectives, covered topics and/or questions addressed, and timing for each module.
Teaching tools include games, examples, exercises, simulations and practical case studies.
Teaching tools include games, examples, exercises, simulations and practical case studies.
Modalités d'évaluation et de suivi
- Final assessment through a multiple-choice questionnaire (MCQ).
- End-of-training satisfaction survey.