What are the classification rules according to EU Regulation 2017/745?

 

According to Annex VIII of the new EU Regulation 2017/745, the classification of medical devices is based on the intended use and the worst-case rule (the highest applies between the multiple applicable classes; the most critical of the multiple intended uses applies).

 

  • Substance-based DM: non-invasive consisting of a substance or mixture of substances, intended for in vitro use, fall into class III.
  • Invasive DMs: they fall into class I if their duration of use is temporary; in-class IIA if the duration is short-term; in-class IIB if long-term.
  • Invasive surgical DM: for short and medium-term use they fall into class IIA; if absorbed or administering medicinal products are in class IIB; if related to the heart, they fall into class III.
  • Class III also includes breast and ear implants, surgical nets, disc prostheses, and active implants.
  • Medical software: class IIA if the software provides information useful for making decisions for diagnostic or therapeutic purposes; if the information could cause the patient's death, the software is in class III; if the information could deteriorate the health conditions, it falls into class IIB; otherwise the software is class I.
  • DM with ancillary medicine: class III
  • Absorbed or locally dispersed DM: they fall into class III if absorbed systemically to achieve their intended use if they achieve their intended use in the gastrointestinal tract; in-class IIA if applied to the skin, in the nasal or oral cavity; otherwise in class IIB.

 

I3CGLOBAL is a leading company providing expert support and advice in Regulatory compliance to pharmaceutical, chemical, and medical device companies.

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