Workshop | Can the Medical Devices Regulation be an engine for for substitution?

On the 6th of November HCWH Europe organised a workshop entitled Can the Medical Devices Regulation be an engine for substitution? kindly hosted by MEP Michèle Rivasi (Greens) in the European Parliament.

The main objective of this workshop was to look at how provisions included in the Medical Devices Regulation can be used to achieve the substitution of medical devices containing harmful chemicals with safer alternatives - the agenda and workshop report are available below.


The 7th Environment Action Program (7th EAP, which guides EU environmental policy until 2020) states that: “The Union will further develop and implement approaches to address combination effects of chemicals and safety concerns related to endocrine disruptors in all relevant Union legislation. In particular, the Union will develop harmonised hazard-based criteria for the identification of endocrine disruptors. The Union will also set out a comprehensive approach to minimising exposure to hazardous substances, including chemicals in products.” (OJEU: L 354/187)

HCWH Europe’s objective in engaging in the policy process is to help phase out endocrine disrupting chemicals (EDCs) and chemicals which are carcinogenic mutagenic or Reprotoxic (CMRs) - particularly phthalates - in medical devices if safer alternatives are available and technically feasible.

Annex I.II.10.4.1 of the Medical Devices Regulation is an open invitation to prioritise medical devices that are benign by design, i.e. devices that are eco-designed. Therefore, HCWH Europe seeks to ensure that Annex I.II.10.4.1 is properly and consistently implemented.

To address this during our workshop, we invited a range of relevant stakeholders asking them whether they are fully aware of the potential of the provisions included in the Medical Devices Regulation and how they are going to avail of them. 


 - An introduction to the new regulations on medical devices and new provisions related to use of hazardous substances

Salvatore SCALZOPolicy and Legal Officer at Unit GROW D.4 - Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW)

 - Industry perspective on hazardous substances requirements in the Medical Devices sector

Jean-Marc ABBING, Chair of Chemicals Working Group - MedTech Europe

 - Sustainability in medical devices: Johnson & Johnson’s perspective

Blandine GAYRAL, Environmental Policy Manager - Johnson & Johnson

 - Sustainability and product stewardship : An industry perspective

Ivan WELVAERT, Director Global Product Stewardship - Becton Dickinson

 - Sustainable procurement in Flemish hospitals

Tomas DELIMON, Environmental Expert - Envicas representing Zorgnet Icuro

 - Public procurement as a tool for substitution of EDCs

Hanna JONSSON, PhD and Chemicals Expert - Stockholm County Council

 - Outcomes of the European PVC-free blood bag project

Lena STIGH, Project Manager - Jegrelius Institute for Applied Green Chemistry