Official Q&A on the extension of the MDR published!

BSI supports its clients with their own FAQ

We are pleased to announce that the highly anticipated Q&A clarifying several aspects regarding the latest extension (Regulation (EU)2023/607) has been published.
We would also like to thank our clients for their valuable feedback, which greatly contributed to the success of last week’s MDSS Seminar. During the seminar, we covered a number of important aspects, with the most pressing question being – when can products can be sold again??? This topic has been addressed in Question 7 of the Q&A: “The extension of the transitional period and the concomitant extension of the certificate’s validity is done automatically by law, …” (subject to certain conditions).

Another important question raised during the seminar was – how to demonstrate the validity of an expired Certificate??? In response to this, Question 7 offers several options:

• Self Declaration based on a harmonized Template;
  • MDSS comment: It would be beneficial if the Commission could publish this template. Alternatively, one could seek help from prominent trade associations in the EU who may have a proposal.
• Confirmation letter issued by the NB acknowledging the receipt of the application and confirming the written agreement is in place, without incurring any extra cost;
  • MDSS comment: The NBs work together on such a letter. However, this letter may not cover all the conditions. The NBs have not received the task to check and confirm that conditions are met due to their constraints in resources.
• The CA should be able to issue Free Sales Certificates;
  • MDSS comment: This could potentially be the most effective approach. The CA would likely conduct checks to ensure that the conditions are met, rather than solely relying on self-declaration
• The Commission will update its factsheets for CA outside the EU;
  • MDSS comment: This could support the manufacturer, however, a third country may still wish to verify that the conditions are met.

We are also excited to inform you that we are working on a one-step approach that will enable the Authorized Representative to support the manufacturer with a single document indicating that all necessary conditions have been checked and confirmed. This will provide our clients with a much-needed solution and will be available in the near future.

BSI has issued their own FAQ, which focuses on the involvement of the NB. They have confirmed that they are working with other NBs on a harmonized letter and have advised those who switched back  or consider to switch back to the BSI normal service, due to the extension, that they will find themselves back in line.

We remain committed to supporting our clients and will continue to provide updates as they become available.

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