{"id":3932,"date":"2023-08-10T14:07:43","date_gmt":"2023-08-10T12:07:43","guid":{"rendered":"https:\/\/www.bayoosoft.com\/?p=3932"},"modified":"2025-08-13T15:56:08","modified_gmt":"2025-08-13T13:56:08","slug":"new-white-paper-product-classification-according-to-mdr-and-ivdr","status":"publish","type":"post","link":"https:\/\/www.bayoosoft.com\/en\/bayoosoft-themis-en\/new-white-paper-product-classification-according-to-mdr-and-ivdr\/","title":{"rendered":"Product classification according to MDR and IVDR"},"content":{"rendered":"

New white paper: Product classification according to MDR and IVDR<\/h1><\/h1><\/div>

The assessment of the risk classes of medical devices and in vitro diagnostic medical devices in accordance with the requirements of the MDR and IVDR is the responsibility of the manufacturing companies. The MDR (EU Regulation 2017\/745) uses four classes (I, IIa, IIb and III) for classification, while the IVDR (EU Regulation 2017\/746) uses classes A, B, C and D. <\/p>\n

The central question is: Which risk class is suitable for your medical device? Before answering this question, it is necessary to consult the regulations to determine whether the product is classified as a medical device at all. <\/p>\n

If you would like a comprehensive overview, we recommend you take a look at our new white paper.<\/p>\n<\/div>

The classification of medical devices:<\/h2><\/div>

They are assigned to the four ascending risk classes I, IIa, IIb and III (from low to high risk). In addition, Class I devices must be differentiated according to sterile use (Is) or the presence of a measuring function (Im). In the context of the IVDR, there are also four classes with ascending risk – Class A, Class B, Class C and Class D – according to which the classification is made. <\/p>\n

Incidentally, standalone software, i.e. medical software that is not used as control software for a medical device (e.g. medical apps), is also considered an active medical device according to the MDR and BfArM. The preparation of the intended purpose and risk classification is therefore the responsibility of the manufacturer and can be carried out after consultation with the notified body if necessary. <\/p>\n<\/div>

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22 Rules of the MDR for medical devices<\/div><\/div>
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The correct classification into the appropriate risk class depends on the intended use of the medical device. To determine this, manufacturers must fulfill the definition for medical devices in accordance with Article 2 of the MDR. <\/p>\n

Once manufacturers have determined the intended uses, the EU Regulation sets out a total of 22 rules in Annex VIII that apply to the further process. A distinction is made between the rules for invasive and active products, as well as special rules for different product types. <\/p>\n

According to the Federal Institute for Drugs and Medical Devices (BfArM), a general assignment to risk classes is not possible.<\/div><\/div><\/div>

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7 IVDR rules for in-vitro diagnostics<\/div><\/div>
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Similar to the Medical Device Regulation (MDR), the classification of products in the In-Vitro Diagnostic Regulation (IVDR) is based on the intended use and the associated risk profile. Seven classification rules have been defined for this purpose. <\/p>\n

Only for Class A medical devices is it possible for manufacturers to confirm conformity independently. For other risk classes, the involvement of a notified body in the conformity assessment process is required. <\/p>\n

Even in the field of in-vitro diagnostics, it is not possible for manufacturers to make a general classification.<\/div><\/div><\/div>

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Everything at a glance: Our new whitepaper<\/h2><\/div>

Do you often deal with the topic of product classification in your day-to-day work and are you looking for an overview that summarizes the most important aspects? Great, then download our new white paper and find out more about risk classification according to MDR and IVDR.<\/p>\n<\/div><\/div><\/div>

Download whitepaper now free of charge<\/h2><\/div>
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