Miriam Di Fonzo -

The Regulation (EU) 745/2017 requires stricter classification rules for substance-based medical devices together with timely pharmaco-toxicological evaluation of components.

Classification Rule 21 and the guidance MDCG 2022-5 need to be taken into consideration for the proper classification and management of the substance-based medical devices.

In order to qualify a substance-based medical device, it is critically important to assess the ancillary nature of the pharmacological, immunological, or metabolic action of its constituent substances.

If their principal action is pharmacological, or immunological, or metabolic, the entire product will be considered a medicinal product and, therefore, will follow a different regulatory pathway, namely that outlined in Directive 2001/83/EC or Regulation (EC) 726/2004. However, when these substances have no pharmacological, immunological or metabolic action or this is ancillary, then the classification of the device will depend on the application of the rules of Annex VIII.

For example, the Rule 21 states that devices that are composed of substances or combinations of substances intended to be introduced into the human body through a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body must be classified as follows:  

  • Class III: substance-based devices that are systemically absorbed by the human body in order to achieve their intended purpose, or if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they are systemically absorbed by the human body;
  • Class IIa: substance-based devices applied on the skin or in the nasal or oral cavity as far as the pharynx;
  • Class IIb: all the other devices that comply with the requirements of Rule 21.

As stated in the MDCG 2022-5, a consultation procedure with a competent medicinal authority or the EMA (the European Medicines Agency) is required for:

  • devices that are systematically absorbed to achieve their intended purpose;
  • when a substance-based device incorporates a substance, which, if used separately, would be considered a medicinal product and when the action of the medicinal product is ancillary to that of the device
  • medicinal products with an integrated device
  • borderline products for which there is uncertainty about which regulatory framework applies.

Regulatory Pharma Net (RPN) is available to provide your company with any updates on the medical device regulatory framework and to assist on all regulatory needs in relation to medical devices including the support for a correct classification of your substance based medical device.

Feel free to contact us at info@regulatorypharmanet.com

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