BSI has initiated an internal project to review our Service Level Agreement (SLA) for IVDR and MDR Technical Documentation. This initiative is designed to align our current understanding of the regulations and provide a more predictable SLA to our valued clients. The IVDR and MDR bring new and increased regulatory requirements, which have created additional responsibilities on all parties.
We want to be confident about the timelines for your submissions to BSI, and the SLA project will enable us to measure and improve our offering across our services.
From February 2021, we have started to collect data and metrics against a draft SLA. Before commencing this initiative, the BSI Operations Project Management (OPM) team has generated a standardized project management process for all Technical teams for the new Regulations. We plan to collect metrics on all IVDR and MDR reviews taking place in Q1 - Q3 2021.
BSI conformity assessment services: initial project proposals:
BSI offers two levels of Technical Documentation review – standard and dedicated. Initially, you'll be provided with a proposal for the services to be undertaken. Once the proposal is signed and returned, we will be ready to accept your document submission.
- Standard Review: Your submission will proceed through our Completeness Check to validate that it contains all the relevant documentation; this can take up to 30 working days. Once your submission is validated, BSI estimates that it will take, on average, ten months to complete the review process.
- Dedicated Review: This pathway is designed to provide structured communication with your BSI technical specialist, on set dates, providing predictability for your project. This requires precise co-ordination of the necessary employees’ diaries on behalf of the manufacturer to work with the BSI technical specialist.
When you opt for a Dedicated Review, we will agree on a date for the review's start to suit your project timelines and BSI capacity. We will expect your document submission at least one week before the agreed review start date. Your submission will proceed through our Completeness Check to validate that it contains all the relevant documentation. Once your submission is validated, BSI estimates that the Dedicated Review process will take, on average, five months from the agreed review start date.
These timelines are dependent on the quality of your submission and on timely responses to BSI questions.
All reviews come with several caveats. BSI can commit to completing its review within the timeframes mentioned; however, if your device requires a medicinal consultation, submission to an expert panel, EU Reference Laboratory, or animal tissue consultation, the timelines may need to include the external reviews, and this can take up to 210 days, for example with a Medicinal Consultation. BSI will aim to complete its portion of the review within the stated timelines; however, items outside of our control may increase the time needed to complete the review (final decision on your Technical Documentation review depends on the outcome of these external experts).
Your submission to BSI
Please be aware that your submission's quality is always the key indicator of meeting timelines; we also require timely responses to questions raised by BSI technical specialists from you and your team. We endeavour to achieve a transparent and collaborative approach to the overall process, so both the manufacturer and BSI must maintain consistent communication and align expectations accordingly. It is always good to remember that not every submission receives a positive recommendation for certification, so a complete and comprehensive submission is critical to success.
SLA project next steps
It is important to note that we will collect data regarding review timelines, and these may shift over time based on feedback, experience and further analysis. We will update you as the project progresses, and more definitive information becomes available.
We appreciate your collaboration during this project and are confident that it will improve our service to you.
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