Impact of Change to IVDR Transition Periods and Certificates issued under the IVDD
This communication is relevant ONLY to CE Certificate Holders under the IVDD. If this is not relevant to you, please ignore this message.
Dear Client,
Further to the client communication issued on 24 November 2021 regarding Transition timelines for IVDD, BSI is contacting you as a Legal Manufacturer with devices certified under the IVDD. Due to the IVDR Transition changes announced, this impacts the potential allowable certification period for devices with a certificate issued by a notified body.
In this communication, we will explain essential actions for you as a Manufacturer, either for potential re-issue of an EC Certificate that has been short-dated to 26 May 2024; or for EC Certificates that would benefit from an early renewal, to take benefit to the new transition period. Please read this message carefully, including the supporting material; You will need to respond to us no later than 28 February 2022.
Below are the steps you need to take if you intend that BSI either re-issues an EC Certificate to its ‘natural expiry date’ (where it has been issued for less than five years to 26 May 2024) or if you intend to initiate an early renewal of your EC Certificate/s if this is possible.
An initial list of possible options for your certificates:
- Revert to natural expiry – eligible certificates have had an expiry date of 26 May 2024 enforced on their IVDD certificate. These certificates will be reverted to 26 May 2025 or the ‘natural’ five-year expiry, whichever comes first.
- Early renewal – eligible certificates that expire between now and 25 May 2024. We will renew the certificates, and they will gain a new expiry date of 5 years or 26 May 2025, whichever is the soonest.
- No change.
Please read the supporting information for all details.
Ineligible certificates include those still in application for IVDD, annex III.6 and those that will gain a renewed expiry date beyond 01 October 2024, unless associated FQA is required for DE (Annex IV sec. 4) certificate validity. We will communicate separately to those who are ineligible; however, if you have questions, please get in touch with your BSI team to confirm.
What do I need to do?
Please ensure you read the supporting material carefully and consider your options. Then, decide on how to proceed with your products and then please let BSI know your plans so that we can action your requests. Please be aware that a cost will be associated with changes to certificates.
We remain fully committed to providing you with comprehensive certification services to help you to meet your goals. However, during this time, additional work to renew and handle IVDD Certifications by 26 May 2022 may impact our delivery of other IVDR reviews. We appreciate your understanding during this time.
If you have any questions or require clarification, please do not hesitate to contact the EC renewals team: ivdnotifications@bsigroup.com.
Yours Sincerely,
Dr Liz Harrison Dr Erica Conway
Global Head – IVD Medical Devices Head of Notified Body – IVD
Regulatory Services (Medical Devices), BSI Regulatory Services (Medical Devices), BSI
