Key points: 

• As shown in the parallel legislative work on the EU Clinical Trials Regulation (CTR), the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR), challenges result when such legislation is implemented and cross-links and impact have not been considered during the legislative process. This challenge may also occur with several legislative works ongoing at the European level that aim to have positive effects on the environmental sustainability of industry, including the pharmaceutical industry

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