We will provide the latest status of MDD in preparation for the MDR transition.
On February 16, 2023, the European Parliament passed a proposal by a majority vote to extend the validity period for high-risk devices that have already obtained MDD until May 2027, and for medium-risk and low-risk devices until May 2028. This decision will officially take effect upon publication in the EU Official Journal. The extension of the deadlines is conditional upon companies that currently hold MDD certification completing their formal MDR applications to the Notified Body (N.B.) by May 26, 2024, and finalizing contracts as stipulated in MDR Annex VII section 4.3 with the N.B. by September 26, 2024. DQS is still accepting new MDR applications, but this decision is expected to prompt a rush of applications for the 70% of products that have not yet applied for MDR, which are currently under MDD. Additionally, even for products that have already obtained MDD, obtaining MDR is a requirement for making design changes, so it is anticipated that resource shortages at the N.B. during the transition period will continue. DQS Japan has decided to establish a consultation desk for companies that have obtained MDD but have not yet applied for MDR regarding future actions. Please feel free to contact our representative for inquiries about future actions or second opinions.

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