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International Clinical Trials

The Impact of the EU MDR on Medical Device Supply Chains

As part of its aim to strengthen device safety, the new EU Medical Device Regulation 2017/745 (EU MDR) accords greater responsibility to each entity in the supply chain. The duty of ensuring device compliance now extends to every organisation involved in bringing a device to market, as well as the manufacturer itself. Considering that supply chains may be large and complex, especially for companies with a presence in multiple markets,compliance with the new requirements may be a significant challenge. However, the delay of the EU MDR date of application by a full year the regulation will now take effect on 26 May 2021 gives businesses the opportunity to properly review the requirements and take the necessary action.

The regulation also widens the net of responsibility to pharmaceutical, biopharmaceutical, and biologic companies. This is because the EU MDR strengthens oversight of device components within drug device combination products. Previously, combination products with a device component ancillary to the drug were regulated under the EU Medicinal Products Directive. Now, under the EU MDR, the device component is subject to the same level of scrutiny as a stand-alone device. Pharma companies must therefore familiarise themselves with the regulation and understand its implications for any of their products that meet the definition of a medical device. If they are not aware of the requirements, they risk losing market access after the deadline for compliance in 2021.

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About the Author

Chad Reynolds is a Director of Maetrics Solutions Delivery and leads out SD teams in Europe. Prior to coming to Maetrics, he spent eight years managing a global service organisation, and 11 years in leading quality and regulatory compliance roles with leading medical device companies. With Maetrics Chad has successfully led a two-year QMS remediation and integration project and serves as a Solutions Delivery Director for some of its largest clients. He has proven skills in global QMS remediation and integration, EU MDR, EOs, ISO 13485:2016 and MDSAP gap identification and assessment, risk management to ISO 14971:2012, and compliance project implementation. Chad is a certified quality auditor to ISO 9001:2015 and ISO 13485:2016.

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