**MEDICAL DEVICES REGULATION** An engine for substitution? **3** **The EU medical devices market** According to the European Commission, the sector has become increasingly important for the health- care of EU citizens and impacts greatly on public expenditure. The medical devices industry is also a major employer in Europe, employing 575,000 peo- ple in the EU. ^**3** According to a 2015 study ( *Medical Devices Sectoral* *Overview - Galway City and County Economic and In-* *dustrial Baseline Study* ), Western Europe represents approximately 25% of the global medical device market, with Germany leading the market followed by France, the UK, and Italy. In Western Europe, 3.7% is the current compounded annual growth rate for the sector whilst Northern Europe is forecasted to have a 5.1% compounded annual growth rate in the next five years. ^**4** **HARMFUL CHEMICALS IN** **MEDICAL DEVICES** In 2014 HCWH Europe published a report entitled *Non-Toxic Healthcare: Alternatives to Phthalates and* *Bisphenol A in medical devices* . ^**5** Its main argument remains valid today - it is better to prevent diseases than to treat them, by choosing better alternative medical devices in daily healthcare to help prevent disease further down the line. PVC (polyvinyl chloride) is a widely used plastic - of- ten made more flexible by the use of the phthalate DEHP, long considered to have toxic characteristics. We have known for decades that phthalates leach out of medical devices such as PVC tubing. ^**5** Alterna- tives were not available 30 years ago but now there is a choice to be made between safer alternatives or ignoring the potential dangers to patients. Similarly, Bisphenol A (BPA) has been linked to en - docrine disruption; initially developed as a synthetic oestrogen in 1891, BPA was not widely used until the second half of the twentieth century due to the availability of more potent synthetic oestrogens, such as thalidomide. ^**5** Now BPA is a major part of daily life: from the ink of cash register paper to the linings of beverage cans – and in medical devices. European legislation was long in the making, but now with the MDR there is a real opportunity to ac- celerate the process of phasing-out these harmful chemicals. **CAN THE MDR BE AN ENGINE FOR** **SUBSTITUTION?** According to the MDR, medical devices will only be permitted to contain levels of certain hazardous chemicals above an established limit if a justification is provided to the Notified Body - which is overseen by the national Competent Authority (see box on page 2). The MDR contains provisions mirroring the REACH requirement for progressive substitution of the most dangerous chemicals when suitable alter- natives have been identified. ^**6** **How does that fit in the wider EU context?** The 7 ^th Environment Action Program (7 ^th EAP) states that: “The Union will further develop and imple-

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