Countdown To 2022 EUEA System As Russia Increases Post-Market Medtech Controls
There are just 4.5 months left until the new harmonized Eurasian Economic Union medtech system becomes mandatory, signifying major changes in regional market access. EAEU member Russia is meanwhile strengthening its post-market medtech controls.
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After a five-year regulatory transition, access to the Eurasian Economic Union market for new medtech products must now take place via the EAEU system only. But having got off to a slow start, further system transitional measures are now under discussion.
The mood among various EAEU member states is that the deadline for system adoption should be extended beyond the end of 2021. So far, the authorities have not budged, though progress on system infrastructure continues to be made, according to local regulatory expert Alexey Stepanov.
26 June saw the release finally of the UK government’s official response to the MHRA’s 2021 consultation on its post-Brexit medical devices regulatory framework. The considered response, held up by political and internal timing issues, represents an implementation plan for reform of the system. Crucially it allows industry extra compliance time.