Table 3.

Product classification and routes for the authorization of medical devices within the EU [135].

Class	Risk	Description	Route
I	Low risk	Non-invasive, does not interact with body	Self-declaration route outlines in Annex VII Module. An EU Declaration of Conformity—manufacturer must declare the device satisfies the provisions of the directive.
IIa	Medium	Generally invasive Therapeutic transfer of energy to patient or used for the diagnosis or monitoring of medical condition	Carry out conformity assessment carried out by NB using Annex II, IV, V, or VI. Can declare conformity with the provisions of directives and regulations (Annex VII).
IIb	Medium	Invasive—surgical or implantation Potential to modify body fluid	Full quality assurance (Annex II)—with assessment by NB of technical documents in one sample in accordance with the directive (Annex II, Section 7).
III	High	Invasive—used to sustain human life, essential to maintain human health Devices connected to CNS or CCS	Full quality assurance system audit (Annex II)—full examination of device by a Notified Body (NB)