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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:

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


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  or contact us at


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