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Countdown to Compliance: Safeguarding Your EU Market Access in Less Than 100 Days – Stay on Track!

Robert Paassen, MSc

The extension of the EU MDR deadline underscores the significance of proactive regulatory compliance. It is crucial for manufacturers to diligently adhere to submission timelines, as any delays can have cascading effects on the entire regulatory process. Timely and thorough document submission is not only a regulatory requirement but also a key factor in ensuring a smooth transition to compliance, ultimately contributing to the overall success of the medical device industry.A

Year of Regulatory Respite

In the past year, many manufacturers strategically utilized the temporary relief offered by the extended transitional provisions. Notified Bodies (NB), responsible for assessing conformity with MDR requirements, even reported a substantial decrease in work and MDR applications. This period provided an opportunity for industry players to recalibrate their regulatory strategies and ensure compliance with the evolving standards.

Deadline Approaching: May 26, 2024

While the past year has granted some reprieve, it's essential to highlight the impending deadline on May 26, 2024. This deadline marks a critical milestone for manufacturers seeking an extension of their (AI)MDD certificates under the new MDR regulations. To be eligible for the extension, manufacturers must submit a valid application for an MDR conformity assessment at a designated Notified Body before the deadline. The potential bottleneck lies in the summer months when Notified Bodies review and approve conformity assessment applications, urging manufacturers to act promptly and utilize expedited services to ensure a smooth transition and meet the May 26, 2024, deadline.

Avoid the Summer Bottleneck

Acting promptly is essential to ensure a seamless transition and to avoid the potential bottleneck during the summer months. With Notified Bodies obligated to review and approve all applications during this period, securing approval before the summer rush becomes most important. Manufacturers should take proactive steps now to guarantee a smooth transition extension without being caught in the bottleneck.

To facilitate a streamlined transition and ease the burden on manufacturers, we can assist you with a valid application for your conformity assessment at a designated Notified Body. Our service is designed to expedite the approval process, providing manufacturers with the assurance they need to meet the May 26, 2024, deadline.

In conclusion

As the MDR transition deadline looms, manufacturers must act swiftly to secure their extension and avoid unnecessary delays and shortage of medical devices for the patients. Qserve can assist you to meet the unique needs of manufacturers navigating this critical juncture, offering a strategic advantage in the evolving regulatory landscape. Don't risk missing the May 26, 2024, deadline – partner with us to ensure a smooth and successful transition to MDR compliance.

For more information, please contact us or read more about our service offer.

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