MDD review trains focus on single-use devices
This article was originally published in Clinica
Executive Summary
The latest text of the European Commission's draft proposal revising the MDD reinforces the need for manufacturers to justify the claims that their devices are for single-use only (SUDs). Industry has called for a ban on the reprocessing of SUDs within the context of the review. Although such a clause places the onus of the manufacturer to ensure that the single-use claim is thoroughly justified, sources close to be Commission have indicated that the only other alternative would have been to allow SUDs to be reprocessed.