Risk classification is the first step in any regulatory approval process for medical devices. It determines which requirements apply in terms of safety, performance, clinical evaluation, and market surveillance, as well as which conformity assessment procedure is to be used. Manufacturers who market their products in the EU and the US face the challenge of having to comply with two different classification systems.
Classification according to MDR
In the European Union, medical devices are classified according to Regulation (EU) 2017/745. Classification is based on clearly defined rules in Annex VIII of the MDR and considers criteria such as intended purpose, duration of use, invasiveness, and location of use in the body. Depending on the result, the product is assigned to one of the Class I, IIa, IIb, or III. As the risk class increases, so do the regulatory requirements, particularly with regard to technical documentation, clinical evaluation, and the involvement of a notified body.
Classification according to FDA
In the United States, classification is performed by the Food and Drug Administration (FDA). Risk is also a key factor for this classification, but additional checks are performed to determine whether comparable products are already approved on the market. On this basis, medical devices are classified into Class I, II, or III. For many Class II products, a 510(k) procedure is carried out to demonstrate equivalence to an existing product. High-risk products usually require premarket approval with extensive evidence.
Due to the different classification systems, a product in Europe and the US is not necessarily assigned to the same risk class. This results in differences in the approval processes, the time required, and the documentation needed.
WQS supports companies in classification according to MDR and FDA, in the regulatory classification of their products, and in the preparation of the necessary documentation.
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More information: Risk Classification in the EU
