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The In Vitro Diagnostic Devices Regulation follows the path of its “sister” regulation on medical devices as the European Commission has extended the implementation guidelines for both legislations due to the delays in compliance which can lead to shor…
The European Commission released on Tuesday a proposal to review the timelines for companies to comply with the In Vitro Diagnostic Medical Devices Regulation to ensure availability and avoid shortages.
Implementation of two regulations on medical devices and in vitro diagnostic medical devices is failing, despite the tweaks made earlier this year, posing shortage risks on one hand and outdated certification rules on the other.
