New position paper on the Proposal for the Regulation of Medical Devices released ahead of Council reading

  • Europe

Brussels, 10 September 2014 –  On 11 September, the European Commission’s proposal for the regulation of medical devices COM(2012)542 will go into first reading at the Council of the European Union’s meeting of the Working Party on Pharmaceuticals and Medical Devices. The issue of chemicals in medical devices is expected to be discussed. 

This follows the adoption of a number of amendments to the proposal by the European Parliament on 22 October 2013. Amongst those adopted, amendment no. 355 to Annex I part II point 7.4 proposed a phase-out of substances that are carcinogenic, mutagenic and toxic to reproduction (CMRs) and endocrine dsrupting chemicals (EDCs) in medical devices. A derogation period will be allowed where alternatives are technically impracticable or are not reliable or safe for patient health.

Health Care Without Harm (HCWH) Europe is highly concerned that patients undergoing treatment can be be exposed to hazardous chemicals in medical devices. Of particular concern are DEHP, which is carcenogenic, genotoxic and reprotoxic, and bisphenol A (BPA), which can interfere with the endocrine system. These substances can leak from medical devices and pose a threat to the patient. A number of hospitals in Europe have already implemented phase-out policies or are using alternative products.

HCWH Europe advocates for a phase out of hazardous chemical when safer alternatives are available and are technically practicable and reliable. Industry has already developed a number of medical devices which do not contain hazardous substances and may be considered safer alternatives. HCWH Europe has developed a database of these safer alternatives.  

“Asking for a phase-out of hazardous chemicals is feasible,” states Executive Director of HCWH Europe Anja Leetz. “We launched our safer alternatives database in July 2014, and have already registered 203 products. This shows that in many cases alternatives are available and it’s reasonable to demand that safer products be used where possible.”


HCWH Europe’s Position Paper on the European Commission Proposal for Medical Device Regulation COM (2012) 542 is now available online.


PRESS: Rosalind Simpson - Communication & Press Officer

E: T: +32 2503 4911 

POLICY: Laurel Berzanskis – Chemicals & Pharmaceuticals Policy Officer

E. T: +32 495 83 24 41

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