Update (2020-04-23): due to the COVID-19 pandemic, the EU MDR date of application has been postponed by 1 year, from 26 May 2020 to 26 May 2021. The possibility for EU-wide derogations for certain critically-needed devices has also been codified. For more information, see Regulation (EU) 2020/561 (link).
Potential extensions or deadline delays for EU MDR are a hot topic. Per the original regulation requirements, the onus is on medical device manufacturers to be ready to identify MDR substances and seek approval once the regulatory framework is in place in 2020. However, companies with a device registered under the legacy system at the 2020 deadline have until the end of their existing registry period to register under EU MDR. After this point, they must continue to register under the EU MDR. If the registered device is changed at any point during this period, it must then be registered under the EU MDR, even if the legacy registration would still be in effect.
- The EUDAMED database launch has been delayed two years, until 2022
- A 4-year delay to the compliance deadline was approved for certain lower-risk medical devices
For other options, please see "EU MDR: What to Do if Your Company Is Unable to Comply by the Deadline".
UPDATE: EU MDR implementation is an ongoing and dynamic issue, especially in light of the COVID-19 pandemic and its effects. Follow Assent's blog for the latest news and updates.
Article current as of 2020-03-18.