2. New classification increases the effort
Classification of medical devices
In the course of MDR, the previous assignment of some medical devices to a class changes compared to the expiring in 2020, previous method according to MDD, AIMDD. Thus, individual software hardly falls into class I, but most software falls into class IIa or higher. Systems, particularly invasive control systems, and implants that used to be Class IIb may fall into Class III. Nanomaterials, orbital products, and drug-delivery products by inhalation, by body-opening or by skin application, may also be affected. Products with animal or human tissue or drug applications (e.g., insulin) have higher requirements.
As a consequence, manufacturers of MDD, AIMDD products must, in due time, review the new classification rules and update their technical documentation, including clinical evaluation (possibly including a clinical trial). Class IIa and IIb medical devices may require a systematic clinical reassessment. The new rule on equivalence of products must be taken into account as well as the options under which a clinical trial can be omitted. If this is omitted, the CE approval can be omitted.