MDR New Applications Open - MDD Extension Proposal Approved by the European Parliament
MDR
We will provide you with 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 with the publication of the EU Official Journal. The extension of the deadline 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 products that account for 70% of MDD-certified products and have not yet applied for MDR by 2024. Additionally, even for products that have already obtained MDD, obtaining MDR will be required for design changes, so the resource shortage at the N.B. during the transition period is likely to continue. Please feel free to contact our representative for any further inquiries or second opinions regarding future actions.
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basic information
DQS Japan is the contact point for DQS Medizinprodukte GmbH to support our customers in Japan. We have established a consultation desk for companies that have not yet applied for MDR regarding future actions.
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For information such as background, please refer to the downloadable materials.
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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.