{"id":8558,"date":"2023-05-03T21:19:58","date_gmt":"2023-05-03T21:19:58","guid":{"rendered":"https:\/\/mdxcro.com\/cumplimiento-del-ivdr-simplificado-la-importancia-de-una-evaluacion-previa-a-la-presentacion-del-ivdr-por-parte-de-mdx-cro\/"},"modified":"2026-04-06T16:10:43","modified_gmt":"2026-04-06T16:10:43","slug":"cumplimiento-del-ivdr-simplificado-la-importancia-de-una-evaluacion-previa-a-la-presentacion-del-ivdr-por-parte-de-mdx-cro","status":"publish","type":"post","link":"https:\/\/mdxcro.com\/es\/cumplimiento-del-ivdr-simplificado-la-importancia-de-una-evaluacion-previa-a-la-presentacion-del-ivdr-por-parte-de-mdx-cro\/","title":{"rendered":"Cumplimiento del IVDR simplificado: la importancia de una evaluaci\u00f3n previa a la presentaci\u00f3n del IVDR por parte de MDx CRO"},"content":{"rendered":"\n

What are the most important things you’ll need to know when it comes to IVDR pre-submission assessment?\u00a0<\/em><\/h2>\n\n

The In Vitro Diagnostic Regulation (IVDR) is a new regulation that took effect on May 26, 2022, replacing the In Vitro Diagnostic Directive (IVDD) and introducing new requirements for manufacturers of in vitro diagnostic medical devices (IVDs). A major change is the increased <\/span>scrutiny of technical documentation<\/span><\/a> by Notified Bodies (NBs).<\/span><\/p>\n\n

To prevent time-consuming and costly NB processes and avoid product rejections, manufacturers can undertake an IVDR Pre-Submission Technical Documentation Assessment with a specialised IVD consultancy like MDx CRO. This assessment comprises a completeness check, consistency check, full review, and comprehensive report.<\/span><\/p>\n\n

Why is an IVDR Pre-Submission Technical Documentation Assessment crucial?<\/h2>\n\n

An IVDR Pre-Submission Technical Documentation Assessment is a valuable tool for manufacturers striving to comply with the new IVDR requirements. Identifying gaps in technical documentation and offering recommendations for enhancement, this assessment helps manufacturers achieve IVDR compliance, thus ensuring a predictable go-to-market strategy.<\/span><\/p>\n\n

Moreover, a pre-submission documentation review prepares manufacturers for the actual Notified Body (NB) review process, enabling them to pinpoint areas needing improvement in their technical documentation and ensuring full preparedness for the NB review.<\/span><\/p>\n\n

What does an IVDR Pre-Submission Technical Documentation Assessment entail?\u00a0<\/span><\/h2>\n\n

The review process starts with a completeness check phase. The <\/span>completeness check<\/b> verifies the submitted technical documentation is complete, searchable, ensuring all required documents are present and that they meet, on a high level, the requirements of the IVDR as per the specific Notified Body <\/span>best practice guidance<\/span><\/a>. The output is a completeness check form verified by MDx CRO and a 1st milestone meeting & presentation.\u00a0<\/span><\/p>\n\n

The assessment proceeds to a <\/span>full technical documentation review<\/a>, <\/b>which involves reviewing all technical documentation submitted by the manufacturer as if it was an actual Notified Body assessment, using our unique knowledge of Notified Body expectations and assessment skills and technique. <\/span><\/p>\n\n

This includes checking that all documents meet the requirements of the IVDR and that they are consistent with each other. The output is a comprehensive report and strategic presentation to the client. The full report includes a summary of identified gaps and tracing them to the corresponding IVDR requirements. <\/span><\/p>\n\n

It also includes a high-level quality plan with an outline of recommendations to achieve IVDR compliance. The solutions range from providing justifications for nonapplicable requirements to providing recommendations for documentation updates, remedial product testing, or closing clinical evidence gaps.<\/span><\/p>\n\n

The final step involves conducting a <\/span>consistency check<\/b>, to verify the coherence of the technical<\/span> documentation. This includes checking that all documents are consistent with each other and that there are no contradictions or errors, including in the intended purpose, product descriptions, codes applied, benefits and risks, among others. <\/span><\/p>\n\n

Inconsistency of technical documentation is one of the top findings of Notified Bodies <\/b>and with limited opportunities for product approval, this is an area manufacturers should be particularly vigilant about.\u00a0 The output of MDx assessment is a redline through the technical documentation for consistency, which will serve as a remediation plan.\u00a0<\/span><\/p>\n\n

What is included in our Full Technical Documentation Review?<\/h2>\n\n

Our assessment of IVD technical documentation includes a comprehensive evaluation of all aspects of the documentation, following a similar process of the Notified Body (NB), in compliance with Annex II and Annex III of the EU IVDR 2017\/746.<\/span><\/p>\n\n

Our analysis involves a comprehensive examination of the documentation’s depth<\/strong>, taking into account various factors such as risk classification, suitability of product claims, intended use, and current industry standards. <\/span><\/p>\n\n

Moreover, we assess the device’s compliance with regulatory requirements and its traceability, from labelling to design inputs, manufacturing, design outputs, verification, validation, and post-market surveillance (PMS).<\/span><\/p>\n\n

Our assessment includes a thorough evaluation of clinical evidence data and the performance evaluation process, ensuring the device’s benefit\/risk acceptability is appropriate. Furthermore, we include an evaluation of post-market surveillance (PMS), including the Post-Market Performance Follow-up (PMPF), to identify any potential issues that may arise with the device’s use and ensure its continued safety and effectiveness.<\/span><\/p>\n\n

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In summary, our assessment covers all aspects of technical documentation review<\/strong> to ensure that the medical device is safe and effective for its intended use, meeting all regulatory requirements.<\/span><\/p>\n<\/blockquote>\n\n

In addition, we provide customized solutions to our clients. One area that manufacturers often seek our expertise is in clinical evidence, which is a popular area for them to validate. As noted by Carlos Galamba, MDx CRO’s Founder and former BSI Internal Clinician, <\/span>\u201cClinical performance alone accounts for 40% of all notified body findings<\/span><\/a>\u201d<\/span><\/p>\n\n

Detailed\u00a0Scope\u200b:<\/h2>\n\n

Our pre-submission technical documentation review can cover some or all of the following areas:<\/span><\/p>\n\n