Clinical classification of the product
Effects of the classification on the effort of the manufacturer
The classification has a significant impact on the necessity and extent of a potentially required clinical evaluation, including clinical trials and clinical PMS.
With a medically justified clinical evaluation, Prof. Zenner and partners can facilitate the correctly justified classification and thereby represent the economic latitudes of the manufacturer, taking into account the patient's well-being.
New classification rules
In the case of a CE-first approval according to EU-Regulation 2017/745 (EU-MDR) as well as a recertification according to the EU-MDR, the medical device (possibly also of products without medical use) will be assigned according to 22 classification criteria (appendix VIII "Classification Rules") for the following classes
Class I CE
Class IM products with measuring function: CE with identification number of a notified body
Class IS sterile products CE with identification number of a notified body
Class IR (New) Reusable surgical instruments CE with identification number of a notified body
Class IIa CE with identification number of a notified body
Class IIb CE with identification number of a notified body
Class III CE with identification number of a notified body
Changes in the classification impacting the clinical evaluation of medical devices by the new 2017 EU MDR
In the case of a CE certification (by 2020 at the latest) or recertification according to EU MDR (latest 2024), the assignment of some medical devices to a class will change compared to the previous MDD, AIMDD, expiring in 2020. Two new classification rules in the field of active medical devices are mentioned in particular:
Under Rule 11, individual software rarely falls into Class I, most software, including software that provides information to make decisions for diagnostic or therapeutic purposes, falls at least in Class IIa or higher, and more specifically if the software can cause the death or permanent impairment of health. From class IIa, a Notified Body is to be involved.
According to Rule 22, a number of systems (eg closed-loop controls, invasive control systems, ie active therapeutic products with integrated or built-in diagnostic function) and implants (eg joint and spinal implants) previously classified in Class IIb now need to meet the requirements of class III products.
Also affected are all products containing or consisting of nanomaterials (Rule 19), body orifice induction products, inhaled drugs (except Surgical-invasive products, Rule 20), products for the introduction of substances or combinations of substances through a body orifice the human body or to the skin and then absorbed by the body or distributed locally in the body (Rule 21).
Products with application of animal or human tissue or drugs (eg insulin) are subject to higher requirements.
Classification and clinical evaluation may also apply to economic operators of the manufacturer
Furthermore, not only the manufacturers but also the suppliers, importers, distributors and sales organizations (economic operators) of the Notified Body can be included in the examination and thus in the clinical evaluation. Exceptions are economic operators of accessories such as screws, wedges, plates and instruments.