{"id":13922,"date":"2015-11-11T10:00:53","date_gmt":"2015-11-11T09:00:53","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=13922"},"modified":"2024-05-23T09:42:18","modified_gmt":"2024-05-23T07:42:18","slug":"mr-002-clinical-research","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/mr-002-clinical-research\/","title":{"rendered":"After the MR-001, the MR-002… procession statement biomedical research"},"content":{"rendered":"

After the MR-001, the MR-002…<\/p>\n

In a previous blog post that you can find here<\/a>, we told you about the RM-001, procedure simplifying the data processing statement during biomedical research at the CNIL-France (National Commission for Data Protection and Liberties). Do you know that this summer, a new methodology of reference, the MR-002, was created? It was published in the Official Journal on August 22nd. In this article we will explain what it is.<\/p>\n

<\/p>\n

\"Nouvelle1- Which study (ies) are concerned\u00a0by the MR-002?<\/h2>\n

Like the MR-001, MR-002 concerns the processing of data of a personal nature. However, it does not apply to Biomedical Research (BMR), but to non-interventional studies of Medical Devices performance in terms of In Vitro Diagnostic (MD-IVD).<\/p>\n

2-\u00a0MD-IVD, what’s that?<\/h2>\n

Remember, the Medical Devices In Vitro Diagnostic are<\/p>\n

\u00ab\u00a0products, reagents, materials, instruments and systems, components and accessories, as well as sample containers, specifically for use in vitro, alone or in combination, in the examination of samples from the human body, for providing information concerning a physiological or pathological condition, actual or potential, or a congenital anomaly, to monitor therapeutic measures, or to determine the safety of a collection of human body elements or its compatibility with potential recipients \u00a0\u00bb\u00a0<\/em>(definition from the Article L5221-1<\/a> of the Public Health Code)<\/p>\n

We can mention as examples of MD-IVD: self-tests, tumor markers, assay reagent of glycated hemoglobin, assay reagent HDL-cholesterol…<\/p>\n

3- The MR-002 principles …<\/h2>\n

The majority points raised by the MR-002 are similar to those of the MR-001. They include:<\/p>\n