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Whitepapers

Understanding the EU Medical Device Regulation for Device Companies

The new European Union (EU) Medical Device Regulation (MDR), effective from May 2020, will significantly impact medical device manufacturers’ product-development timelines. All companies intending to sell their devices in Europe must understand the new MDR and how it differs from previous directives, particularly regarding new biocompatibility standard requirements.

The MDR introduces stricter requirements and mandates CE marking for some products that did not previously require it. Adherence to ISO 10993-1:2018 is now compulsory, and this updated standard has more stringent guidelines in several areas, making additional testing necessary. This increased testing could take a significant amount of time to perform, potentially delaying product approvals.

Medical device companies must account for the extra time and expense associated with these new requirements to avoid delays in EU product approvals. By understanding and preparing for the changes brought by the MDR, companies can ensure their products meet the new standards and continue to be marketed in the European Union. This whitepaper provides a proactive approach that will help maintain compliance, ensure patient safety, and secure market access under the new regulatory framework.

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