Technical Documentation submission guidance to meet your IVDR/MDR timelines

News: 29 April 2021

BSI is currently working in unprecedented circumstances, with increased requirements and a positive stream of applications for:

• EU In Vitro Diagnostic Regulation (IVDR),
• EU Medical Device Regulation (MDR)

We 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 750 colleagues within BSI Medical Devices. However, the increased requirements mean that the BSI team is under immense pressure to meet your requests to maintain market access for your products.

Due to the finite capacity within the BSI EU Notified Body (2797) 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.

Guidance dates for submission per EU

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

We remind Active Implantable Medical Device and Medical Device Directive (AIMD and MDD) certified manufacturers to apply for the MDR as, post the Date of Application on 26 May 2021, you will not be able to make significant changes in the design and intended purpose of the products under the AIMD/MDD.

BSI will strive to ensure your new certificates are issued by the end of the MDR transition date of 26 May 2024.  BSI is pleased to accept your MDR application under our standard rate review offering up to 26 January 2023. As time shortens, we are still happy to receive your submissions; however, submissions received between 27 January 2023 and 26 May 2023 will be required to be conducted at our dedicated rate service.

Finally, BSI is always willing to accept submissions beyond 27 May 2023; however, we will be unable to ensure that you have certificates in hand prior to the end of the regulatory deadline. In the same way, deadlines apply directly for the IVDR in order to ensure proper timing for certificate issuance.

The following chart can be used as a quick reference guide to the important dates and timeframes we have defined. 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 will keep you informed as the situation progresses.  
 

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.
• The certification decision will be dependent on the submission of largely satisfactory documentation and timely responses to questions raised by BSI.

We hope that providing this information early will allow you to ensure your regulatory strategy considers the length of time needed for BSI to complete the review process. We aim to meet all requests on existing and new work within the timelines outlined; our priority remains to maintain patient safety and ensure thorough and robust reviews for all products.

Who can I contact for further information?

Please contact your Account Manager to discuss your situation. They will be able to answer your questions in the first instance, and we recommend you use the free material.