MDR Technical Documentation submission guidance

Following our communication to you in March 2021 on Technical Documentation submission timelines, we would like to provide you with an update. The original communication confirmed the following two critical points: 

• Due to the finite capacity within the BSI EU Notified Body (2797) and BSI UK Approved Body (0086), we advise that you send your submissions to us urgently. Please do not leave your submission until the last few months before the regulatory deadlines, as this will be far too late for BSI to react and complete the necessary due diligence to the reviews.
• Please be aware that the dates in the table are based on our current resource assessment and will be subject to adjustment over time.

We continue to support the changes to the regulatory environment and have recruited heavily over the last few years; we are proud to say that our team has grown to over 950 colleagues within BSI Regulatory Services. But, as we have learned more about the depth of the MDR review process, the time required to complete our reviews, and the magnitude of applications from the market, we would like to provide you with an update on the published dates.

Guidance dates for submission for MDR Applications and Technical Documentation

The dates given in the table below are when we need to have received your signed proposals and a complete set of Technical Documentation for all the relevant devices ready for us to start our review; these are not the dates for beginning an application.

BSI will strive to ensure that we complete our conformity assessments and, upon positive outcomes, issue your MDR certificates by the end of the MDR transition date of 26 May 2024. Bearing in mind the 26 May 2024 deadline, we will continue to accept MDR applications under our standard rate review offering until 1 October 2022 and MDR applications under our dedicated rate until 1 January 2023. As time shortens, we are still happy to receive your submissions; however, BSI is unable to assure that we will complete our conformity assessments by May 2024 for any submissions received after 1 January 2023.

The following chart is a quick reference guide to the critical dates and timeframes we have defined. Technical Documentation submissions are required to be compliant with the Regulation. For all questions raised during the review, BSI will provide you with a response timeline. If responses are not delivered within this timeline, BSI will not be able to ensure the completion of our conformity assessment activities prior the end of the MDR transition date. 
 

Please note:

• Acceptance by BSI of a signed proposal and a complete set of Technical Documentation does not constitute a guarantee that work can be completed before the end of the transition period. However, your support in meeting the deadlines above will give us the best opportunity to complete the review process in time.
• Dedicated reviews will be scheduled by agreement ahead of submission, whilst Standard reviews will be planned one round at a time after submission. The reviews may not commence straight after submission and will be scheduled based on resource availability.
• Timelines specified above are contingent on the submission of largely satisfactory documentation and timely responses to questions raised by BSI.

Our priority remains to maintain patient safety and ensure thorough and robust reviews for all products within the new regulatory framework.

Changes under the AIMDD and MDD

Any AIMDD or MDD Change Notifications needing a review, that does not trigger an MDR application per Article 120 and MDCG 2020-3, must be submitted no later than 1 October 2022. Otherwise, these will need to be prioritized after our MDR work. The only exceptions to this date are changes that are essential to address safety or performance related field corrective actions or that would interrupt the market supply of the device.

For change notifications that meet the exception criteria but may require  supplementary medicinal or animal tissue Competent Authority consultations BSI will only accept these submissions conditional on Competent Authority resources being available at that time.

Who can I contact for further information?

Please get in touch with your Account Manager to discuss your situation. They will be able to answer your questions in the first instance, and we recommend you use our free resources.

Yours sincerely,

Dr Michael Weissig
Global Senior Vice President Commercial