Classification based on risk and clinical impact
Manufacturers of medical devices (MDs) are required to classify medical devices in order to better assess their risk and clinical impact. The aim is to protect patients, healthcare professionals and any other person using the equipment. Indeed, the use of these devices is not without risk.
There are four distinct classes which are categorised depending on the health risk posed by the medical devices:
- Class I: the risks are low for these medical devices which include corrective spectacles, wheelchairs, crutches, etc. ;
- Class IIa: the potential risk is measured and moderate for devices such as hearing aids, contact lenses, dental crowns… ;
- Class IIb: higher risk: this class includes lens disinfectants, condoms, infusion pumps… ;
- Class III: Class III medical devices represent a high risk and comprise devices such as breast implants, hip prostheses, etc.
It is up to the manufacturer to determine the class in which his products fall, with reference to European directives. The class depends on a number of factors such as whether the product is invasive or implantable, its purpose (diagnostic, therapeutic, surgical, etc.), its active nature, the parts of the body concerned, its duration of use, etc. MGA Technologies designs and manufactures medical devices. Our mastery of current standards and regulations enables us to assess the risks and clinical impact of our products and classify them appropriately.
Medical device classification: standards and guidelines
The criteria used to classify medical devices are set out in Annex IX of Directive 93/42/EC on medical devices. The MEDDEV 2.4/1 guide provides further details and illustrations for each point of the annex.
Finally, the guide for “ambiguous” classifications is regularly updated by the European Commission. Manufacturers can consult it to optimise the classification of medical devices such as hand disinfection products, air decontamination devices, tooth whitening products, etc.
The appendix is divided into 3 parts. The “Definitions” section explains the terms used in the medical device classification criteria. The “Application rules” section explains how the criteria are to be used. The final section, “Classification rules”, sets out the rules for classification in a number of cases.
Case studies in medical device classification
Regulations governing medical devices are harmonised within the European Union. They apply to all manufacturers, who must comply with them. For their products to be validated, they must be classified and CE marked (Conformité Européenne).
Manufacturers can obtain the CE mark by establishing a file demonstrating that they comply with European directives in the manufacture of medical devices. Before the mark is awarded, an organisation verifies that the devices comply with the directives, and awards a classification.
MGA Technologies, your medical device supplier partner
MGA Technologies is a designer, manufacturer and supplier of medical devices. We guarantee that our products comply with European directives. We apply the classification of medical devices, taking into account their level of risk and their medical impact. We offer our skills to any company, including major accounts, for the design and manufacture of medical devices, instruments and process equipment. We can operate on a CDMO/CMO basis.
Find out more about our services by contacting our engineers.
