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Showing 20 results out of 10000
23 Mar 2023 | Partner Content

e-IFU requirements translated for implantable medical devices

After the European Commission published the Commission Implementing Regulation (EU) 2021/2226 on 14 December 2021 - laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council with regards to electronic instructions for use of medical devices, replacing the Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices, a new era began.