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Orthotics and insoles: Are they medical devices? Do they need CE marking?

Some product groups can put manufacturers in a difficult position, as they are not always able to place their product in the appropriate legal context. Possible errors of evaluation can also occur for categories such as orthotics and insoles that, as a start, can be considered as simple clothing accessories. However, it should be specified that in many cases insoles and orthotics are to be placed in the category of medical devices.

According to the legislation currently in force, i.e. Directive 93/42/EEC as adopted by the single EU Member States, these are products intended to be used with a medical purpose. Consequently, if orthotics and insoles claim either any improvement for the health of the user or that they prevent health from getting worse, for instance in terms of relief of some issues related to a bad posture, they fall into the field of application of medical devices. Depending on the manufacturing process, orthotics and insoles can be legally framed as either medical devices or ‘custom-made’ medical devices.

When insoles and orthotics are manufactured in an assembly production, these product are class I medical devices. This implies the need by the manufacturer to start a procedure to assess their conformity by drafting a Declaration of Conformity. At the end of this, the manufacturer can apply the CE marking on the products with no need of a control by a third body (Notified Body). The CE marking is provided for also on insoles and orthotics requiring to be adjusted by users (for instance, by cutting them to fit their shoes). This kind of insoles and orthotics are fully fledged medically devices, and are therefore subject to the provisions of the Italian adoption of Directive 93/42/EEC.

On the other hand, in the cases when insoles and orthotics are made based on the prescription of a doctor specifically for a given patient, these products are ‘custom-made’ medical devices. These devices do not need a CE marking but, in any case, the manufacturer shall submit a declaration defining that the products are compliant with the essential requirements provided for by the Directive. Custom-made medical devices are not subject to the obligations of a registration as other medical devices; however, Italian manufacturers of custom-made medical devices shall enrol in the List of manufacturers and authorized representatives of custom-made medical devices located in Italy before marketing their products. This list also requests to indicate a field of application (that for insoles and orthotics is either orthopaedics or podiatry depending on the specific intended use).

As of 26 May 2021, Directive 93/42/EEC will be repealed by Regulation (EU) 2017/745. Manufacturers shall comply with the prescriptions of the new norms, that in principle, provide for stricter requirements. In any case, from the point of view of legal frame and classification there will be no changes for insoles and orthotics as they will continue to be classified as either class I medical devices or custom-made devices according to the previous definitions.

Scritto da: Daniele Scarpino

Foto di Free-Photos da Pixabay