5/26/2023 0 Comments Ce technical file sample![]() For example, factors such as the degree of invasiveness, the part of the body affected, time in contact with the body and whether or not the device is active are considered when classifying devices. Examples include medicinal products, personal protective equipment, or lifestyle software without a medical purpose.īy using the applicable regulations, every device is then classified according to its risk. Some products may initially seem to fit the MD or IVD definition, but further assessment can conclude that they are not devices. The product’s qualification consists of evaluating whether it falls under the EU Medical Device Regulation EU MDR 2017/745 (MDR) or the In vitro diagnostics medical device Regulation EU IVDR 2017/746 (IVDR), respectively. Once the product’s intended purpose is defined, the following steps include its qualification and classification. Note that the intended purpose must be consistent and present across all product documentation (technical documentation, clinical evaluation, labelling, instructions for use, promotion and sales material). ![]() ![]() The definition of the intended purpose will allow the device qualification (section 2) and classification (section 3). The intended purpose should be a concise statement (two to three sentences) that indicates the use for which the device is intended according to the manufacturer’s information. Defining the intended purpose is crucial when planning the road to CE marking.
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