IVDR Documentation Submission – Best Practices
BSI Medical Devices - A designated EU Notified Body. A UK Approved Body. An accredited ISO 13485 Certification Body published Best Practice Guidelines for IVDR Documentation Submission.
These guidelines and our experts' experience will ensure a smooth certification process for your In-Vitro Diagnostic Medical Devices. By now, everyone is aware of the significant changes and challenges for IVD manufacturers as IVDR has increased clinical evidence requirements, new classification rules, more involvement of notified bodies, and stricter post-market surveillance obligations. This 'Best Practice' guidance document from BSI has made things easier for IVD Manufacturers as it provides practical advice and recommendations on preparing a successful documentation submission for the IVDR. The document is aligned with Annex II and III requirements of the IVDR, which specify the general safety and performance requirements and the technical documentation contents for IVDs.
The document covers topics such as:
- Submission and technical documentation contents: what information to include in your submission, how to structure your technical documentation, and how to provide a clear and complete context for your submission.
- Verification of performance: how to demonstrate the scientific validity, analytical performance, and clinical performance of your IVDs, and what types of studies and data to provide.
- Submission method: how to submit your documentation electronically via BSI's online portal or via physical media.
- Submission process: what are the steps and timelines involved in the submission process, and how to communicate effectively with BSI during the review.
- Novelty: how to determine if your IVD is novel or not, and what are the implications for your submission.
The document includes two appendices with information to provide in a technical document submission and reference documents that can help you better understand the IVDR requirements.
Along with these guidelines, IVD manufacturers should focus on
- Undertaking Gap Analysis: IVD manufacturers should assess their current compliance status and identify gaps or areas of improvement.
- Strategy Development: Irrespective of the IVDR deadline approaching, IVD Manufacturers must develop a realistic and effective strategy for achieving compliance with the IVDR, considering your business goals, resources, and timelines.
- Post-Market Surveillance: IVD Manufacturers must establish and maintain a robust post-market surveillance system that complies with the IVDR requirements and enables them to monitor and improve the safety and performance of the IVDs.
Regulatory experts at Med-Di-Dia have extensive knowledge and experience in working with BSI and other notified bodies, as well as with national competent authorities and other stakeholders. We can help you navigate the complex regulatory landscape of the EU and ensure that your IVDs are ready for the market.
If you are interested in our services or want to learn more about how we can help you with the IVDR transition, please fill this form https://mailchi.mp/1ca078737f9c/ivdr or contact us at mdd@mddltd.com
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