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A European Union survey in late found 23, devices would need to be re-certified or withdrawn. And, until the approval to delay the transition period, as many as 17, certificates under the Medical Devices Directive were due to expire in Not surprisingly, this raised huge concerns about loss of products on the EU market. Nevertheless, much still remains unclear. Will the extensions apply to all manufacturers? If those products are still in the queue for notified body review by the end of the extension, will they automatically come off the market? If no contract has been signed with a notified body as yet, what does that mean for the product? There is not a lot of information around what the delay actually means for each individual device manufacturer and how it impacts their current situation. The notified bodies have long been flagging their concerns over conformity assessments and the fact that certificates were likely to expire before products could be assessed. However, the commission had been optimistic that a lot of companies would start early and that more devices would have gone through the MDR by this stage. They did not anticipate all the issues with the notified bodies, such as resourcing challenges, or consider the fact that the notified bodies would have double the workload as they continued to support products under the directive while handling MDR assessments. As a result, there was a lack of planning, forcing the commission to scramble to prevent massive numbers of products from going off the market.