שלום רב,

לאור השינויים באמ"ר משרד הבריאות , אשמח לחדד מעט מהי חלוקת קלאסים בתחום הציוד הרפואי

חשוב לציין כי משרד הבריאות הישראלי פועל בכפוף לאירופה וארה"ב.

האישורים בישראל ניתנים על פי האישורים בחו"ל ולפי חלוקת הקלאסים בחו"ל.

חלוקת קלאסים- דרגות סיכון בתחום הציוד הרפואי

קיראו:

Classification

The regulatory authorities recognize different classes of medical devices, based on their design complexity, their use characteristics, and their potential for harm if misused. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into

consideration

The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.The classification procedures are described in the Code of Federal Regulations , Title 21, part 860 -usually known as 21 CFR 860

European Union (EU) and European Free Trade Association EFTA

The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC.

There are basically four classes, ranging from low risk to high risk.

• Class I
• Class IIa
• Class IIb
• Class III

. Medical devices that pertain to class I (on condition they do not need to be sterilised or are not used to measure a function) can be put on the market purely by self-certification.

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