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  4. Eco-design of Medical Devices

Eco-design of Medical Devices

Dernière mise à jour : 18/05/2026

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.

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).

Prérequis

No prerequisites

Programme

  1. 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).

 

  1. 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

 

  1. 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

 

  1. 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

 

  1. 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

 

  1. 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

 

  1. 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)

 

  1. The first steps to implement your ecodesign project
  • Finding subsidies
  • Define a roadmap

 

 

  1. 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.

Modalités d'évaluation et de suivi

  • Final assessment through a multiple-choice questionnaire (MCQ).
  • End-of-training satisfaction survey.

M'inscrire à la formation

Toutes nos formations peuvent être accessibles aux personnes en situation de handicap. Chaque situation étant unique, nous demandons à nos clients de bien vouloir préciser le handicap lors de la sollicitation. Ceci afin de pouvoir vous confirmer l'ensemble des possibilités d'accueil et permettre au participant de suivre la formation dans les meilleures conditions.

Pour toutes informations complémentaires nous conseillons les structures suivantes AGEFIPH (www.agefiph.fr), FIPHFP(www.fiphfp.fr). Nous tenons également une liste de partenaires mobilisables le cas échéant.

  All our training sessions are accessible to individuals with disabilities. As each situation is unique, we kindly ask our clients to specify the disability when making inquiries. This allows us to confirm all possible accommodations and enables participants to undergo training under the best conditions.

For further information, we recommend the following organizations: AGEFIPH (www.agefiph.fr), FIPHFP (www.fiphfp.fr). We also maintain a list of partners who can be mobilized if necessary.

S'inscrire

Vos formations

Les tarifs indiqués sont ceux pratiqués pour les sessions au format Inter-entreprise. Pour les sessions Intra-entreprises ou individualisées merci de nous contacter afin d'établir un devis.

 The prices indicated are for sessions in the Inter-company format. For Intra-company or customized sessions, please contact us to establish a quote.

Session sélectionnée

  • COMPLÈTE

Prochaines Sessions

  • Cette formation n'est pas programmée pour le moment en format en inter-entreprise.

    Si vous êtes responsable formation, vous pouvez faire une requête afin d'obtenir un devis pour l'organisation d'une session en INTRA dans votre entreprise.

    Vous pouvez également nous contacter (via l'onglet contact en haut de page) pour nous faire part de votre besoin, des sessions inter peuvent être organisées dans le cas ou plusieurs demandes nous sont formulées.

    This training is not currently scheduled in the inter-company format.

    If you are in charge of training, you can request a quote for organizing an INTRA session within your company.

    You can also contact us (via the contact tab at the top of the page) to let us know your needs; inter-sessions can be organized if multiple requests are received.

Dans la même catégorie

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Handicap et adaptation :

Toutes nos formations peuvent être accessibles aux personnes en situation de handicap. Chaque situation étant unique, nous demandons à nos clients de bien vouloir préciser le handicap lors de la sollicitation. Ceci afin de pouvoir vous confirmer l'ensemble des possibilités d'accueil et permettre au participant de suivre la formation dans les meilleures conditions.

Pour toutes informations complémentaires nous conseillons les structures suivantes AGEFIPH (www.agefiph.fr), FIPHFP (www.fiphfp.fr). Nous tenons également une liste de partenaires mobilisables le cas échéant.

 

Disability and adaptation:

All our training sessions are accessible to individuals with disabilities. As each situation is unique, we kindly ask our clients to specify the disability when making inquiries. This allows us to confirm all possible accommodations and enables participants to undergo training under the best conditions.

For further information, we recommend the following organizations: AGEFIPH (www.agefiph.fr), FIPHFP (www.fiphfp.fr). We also maintain a list of partners who can be mobilized if necessary.

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