We will deliver the latest information on MDR. This time's theme is "What are the 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 already certified under the MDD until May 2027, and for medium-risk and low-risk devices until May 2028. The official announcement was published in the EU Official Journal on March 20, 2023. The extension of the deadline is conditional upon companies that have obtained current 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. Only legacy devices under the MDD (MDCG 2021 25), meaning devices that were placed on the market after the application date of the MDR (May 26, 2021), are eligible to apply for the extension. DQS is still accepting new MDR applications, but this decision is expected to prompt a rush of applications for the 70% of MDD-certified products that have not yet applied for MDR by 2024. Additionally, even for products already certified under the MDD, obtaining MDR certification will be necessary for design changes, so the resource shortage at the N.B. during the transition period is likely to continue.
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basic information
DQS Japan is the contact point for DQS Medizinprodukte GmbH to support customers in Japan. We have established a consultation desk for companies that have not yet applied for MDR regarding future responses.
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Please refer to the downloaded materials for the conditions of the extension.
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Company information
DQS Japan is a specialized organization with a headquarters in Germany and over 30 years of experience. As a partner to Japanese medical device manufacturers, we provide medical device certification services for both Japan and Europe. In Japan, we operate as a registered certification body, conducting certification for highly controlled medical devices and controlled medical devices. For Europe, we serve as the contact point for DQS Medizinprodukte (DQS Medical Devices), which is a Notified Body under the MDR.