Whitepaper:
EU MDR & the Impact on Chemical Substances in Medical Products

In April 2017, the European Union (EU) adopted the new Medical Device Regulation (MDR), (EU) 2017/745 EU MDR. This new regulation is replacing the two existing directives – the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD). After a three-year transition period, the new Medical Device Regulation will enter into effect on May 26, 2021.

 


The new EU MDR explains the need for a risk assessment to identify if any of the CMR 1A and 1B substances, listed in the Regulation (EC) No 1272/2008 - Classification, Labelling and Packaging (CLP), are in your materials that are considered “invasive.” This means that devices shall be designed and manufactured in a way that aims to reduce the possible risks posed by substances or particles such as wear debris, degradation products, and processing residues that may be released from the device. 

This paper highlights the impact the new MDR will have on chemical substances in medical products, important changes and new requirements, proposed solutions, and long-term considerations to ensure compliance by the May 2021 deadline. 

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