Since these devices come into contact with the human body for varying periods of time, it is essential that every stage of their production is carefully controlled.
According to Regulation (EU) 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended to be used on human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, injury, or disability;
- investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state;
- providing information by means of in vitro examination of specimens derived from the human body.
Under current legislation, medical devices are grouped into different risk classes, ranging from Class I (lowest risk, including devices such as tongue depressors or home blood pressure monitors) to Class III (high risk, such as pacemakers, defibrillators, implanted prostheses).
The risk class depends on the duration of contact between the device and the body, the degree of invasiveness, whether the device uses an energy source to function, its effect on the circulatory or nervous system of the body it comes into contact with, its diagnostic impact, and whether the device incorporates a medicinal substance.
In vitro diagnostic medical devices, on the other hand, are governed by Regulation (EU) 2017/746, which divides them into four classes: from A (lowest risk) to D (highest risk).
The regulations applicable to medical devices are governed by ISO 13485 and ISO 14971, which define the quality standards for each stage of the medical device life cycle, ensuring the continuous application of best manufacturing practices. Since medical devices are designed to penetrate the skin or interact with the human body, compliance with these standards is of fundamental importance. For these reasons, environmental controls are an essential element for the successful design and implementation of a medical device, making the optimal design of controlled contamination environments crucial to ensure the safety and effectiveness of the final product.
The cleanrooms designed and built by Propharmabi, in ISO Class 5 or ISO Class 7, defined according to the needs of the production process and the required level of sterility, reduce the risk of contamination and ensure high product quality.
