The new European Union (EU) Medical Device Regulation (MDR) will 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 the previous directives, especially in terms of new biocompatibility standard requirements. The regulation, which goes into effect in May 2020, mandates CE marking for some products that did not previously require it. The new regulation will require adherence to ISO 10993-1:2018, which has also been updated to have stricter guidelines in certain areas. This will make more testing necessary, that could take a significant amount of time to perform. Device companies need to account for this extra time and expense to avoid delays in EU product approvals.