One of the main changes that will most affect the Medical Device regulatory field is included in Annex VIII of the new Regulation EU 2017/745 (MDR 2017/745).
This Annex concerns the Medical Devices new classification rules that will be stricter than those currently stated in Annex IX of the Directive 93/42/CEE. The new rules will lead many devices to be classified in a higher risk class starting from the entry into force of the MDR 2017/745.
The new classification Rule 21 refers to the medical devices composed of substances or combinations of substances and that are 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 into the human body.
Rule 21 will apply to medical devices as follow:
- all the devices that comply with the requirements of Rule 21 shall be classified as class III (highest risk) if they 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;
- if instead, this kind of devices are applied on the skin or in the nasal or oral cavity as far as the pharynx, they shall be classified as class IIa;
- all the other devices that comply with the requirements of Rule 21 shall be classified as class IIb.
This new classification rule will affect a wide cluster of medical devices, part of them currently in risk class I according to the Directive 93/42/CEE. For medical devices currently classified as class I, this rule may have a great impact. In fact, up to now these devices can be easily CE marked with a self-certification by the Manufacturer, who has only to declare the compliance with the requirements of the Directive 93/42/CEE. Whereas, applying the new classification rules of MDR 2017/745, the risk class of this kind of devices will increase with an unavoidable consequence: demonstration of MDR 2017/745 requirements by the Notified Body conformity assessment (for further information on this topic, please click here).
Regulatory Pharma Net offers regulatory support to the Medical Devices companies to be compliant with the requirements of the new MDR 2017/745. We are available for any clarification, do not hesitate to contact us!