326. Deputy Noel Grealish asked the Minister for Health if the Government will call for an extension of medical device directive certificates (details supplied) until the notified body capacity is resolved, in order to maintain patient access to vital medtech that are already safely in use in the market, given that as much as 85% of the 500,000 devices covered under the previous medical devices directive are yet to be certified under the new MDR due to bottlenecks in the overburdened notified bodies system; and if he will make a statement on the matter. [52494/22]

Summary

326. Deputy Noel Grealish asked the Minister for Health if the Government will call for an extension of medical device directive certificates (details supplied) until the notified body capacity is resolved, in order to maintain patient access to vital medtech that are already safely in use in the market, given that as much as 85% of the 500,000 devices covered under the previous medical devices directive are yet to be certified under the new MDR due to bottlenecks in the overburdened notified bodies system; and if he will make a statement on the matter. [52494/22]

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