Where And How eIFU Rules Will Apply Under The EU’s Medical Device Regulation
Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A new Implementing Regulation explains how these apply under the Medical Device Regulation.
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The EU needs to go further when it comes to allowing the use of electronic IFU for all professional use medical devices and fall more closely into line with other global markets.
The European Commission has issued a report in a move intended to extend its powers to amend the MDR and IVDR in places where the text of the regulations allow this.
The Commission will present a mixture of likely elements of a legislative proposal for a targeted amendment of the MDR and IVDR for consideration at the 9 December EPSCO Health Council meeting.