We will provide the latest information on MDR. [This time's theme] Conditions for the extension of the MDD transition period.

On March 15, 2023, the European Council 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 and low-risk devices until May 2028. The official announcement was published in the EU Official Journal on March 20, 2023.
For the conditions regarding the extension of the MDD transition period, please refer to the downloadable materials.
DQS is still accepting new MDR applications, but this decision is expected to prompt a rush of applications to Notified Bodies (N.B.) for products that account for 70% of MDD-acquired products that have not yet applied for MDR by 2024. Additionally, even for products that have already obtained MDD, obtaining MDR will be a requirement for design changes, so the resource shortage at N.B. during the transition period is expected to continue. Therefore, 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, including second opinions.

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