{"id":2873,"date":"2022-05-18T10:19:00","date_gmt":"2022-05-18T08:19:00","guid":{"rendered":"https:\/\/www.bayoosoft.com\/?p=2873"},"modified":"2024-07-03T10:20:41","modified_gmt":"2024-07-03T08:20:41","slug":"how-are-medical-devices-classified-according-to-mdr","status":"publish","type":"post","link":"https:\/\/www.bayoosoft.com\/en\/bayoosoft-themis\/how-are-medical-devices-classified-according-to-mdr\/","title":{"rendered":"How are medical devices classified according to MDR?"},"content":{"rendered":"

How are medical devices classified according to MDR?<\/h1><\/h1><\/div>

Medical devices are subject to the risk classes defined in the Medical Device Regulation (MDR). In accordance with Regulation (EU) 2017\/745 (MDR), classification is into four classes I, IIa, IIb and III (low to high risk in ascending order). But what exactly is the classification based on? And who has to act accordingly?<\/p>\n

What counts for now, however, is the question: Is the product really a medical device? Or is it a non-medical device, accessory or even in-vitro diagnostics (IVD)? The answer to the definition can be found in Article 2 of the MDR.<\/p>\n

Accordingly, a medical device is “an instrument, apparatus, appliance, software, implant, reagent, material […] which, according to the manufacturer, is intended for human use and which, alone or in combination, is intended to fulfill one or more […] specific medical purposes.” Source<\/a><\/p>\n<\/div>

Classification of in-vitro diagnostics (IVD) – how are they classified?<\/p>\n<\/div>

What are in-vitro diagnostics (IVDs) and what risk classes are IVDs classified into? Read more in our blog post.<\/p>\n<\/div>

Learn more<\/span><\/a><\/div><\/div><\/div>
\"BAYOOSOFT<\/span><\/div><\/div><\/div><\/div>

Once it has been determined that the product is a medical device in accordance with the MDR, the labeling, instructions for use and advertising materials as well as the actual intended purpose are determined. Manufacturers determine the intended purpose individually for each product. For this purpose, a definition for medical devices according to Article 2 of the MDR must be fulfilled.<\/p>\n

Based on this intended purpose, the medical device is assigned to a risk class. The regulation in Annex VIII of the MDR provides a total of 22 rules for classifying the product into the respective product class.<\/p>\n

The manufacturer of the medical device or their authorized representative is responsible for the risk classification. Not quite so simple: The Federal Institute for Drugs and Medical Devices (BfArM) rules out a blanket classification into risk classes based on product groups, as the classification is always based on the intended purpose and individual information provided by the manufacturer.<\/p>\n<\/div>

\"BAYOOSOFT<\/span><\/div><\/div><\/div>

Good to know<\/p>\n<\/div>

If a medical device is used in conjunction with another product, a separate classification must be made for each. Accessories for a medical device are also classified separately.<\/p>\n<\/div><\/div><\/div><\/div>

Risk classification in just a few steps<\/h2><\/h2><\/div>

In order to provide you with the best possible support for classification <\/a>in accordance with the Medical Device Regulation (MDR Article 51(1)), we have fully integrated the functionality for classifying the medical device into classes I, IIa, IIb or III in the BAYOOSOFT Risk Manager<\/a>. Using an interactive questionnaire, you are guided through the classification process and can output the result as a report.<\/p>\n

This will give you an initial indication of the classification. In addition, you only have to provide a justification for the classification, taking into account the intended purpose and the designation of the rules applied.<\/p>\n<\/div><\/div><\/div>

Get to know the BAYOOSOFT Risk Manager<\/p>\n<\/div>

The efficient way to technical documentation: BAYOOSOFT Risk Manager supports you in the creation of technical documentation for medical devices and in-vitro diagnostics. All relevant information is recorded in a clearly structured environment, stored centrally in an audit-proof manner and dynamically linked with one another at a fine granular level. This automatically prevents redundant data storage. Reports are generated with the latest data at the touch of a button.<\/p>\n<\/div>

Test now<\/span><\/a><\/div><\/div><\/div>
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