What are the classifications for devices classified under the medical device Directive in the EU?
What are the classifications for devices classified under the medical device Directive in the EU?
The MDR designates four medical device classifications: Class I. Class IIa. Class IIb….Class I Medical Devices
- Class Is: The medical device must be presented sterile.
- Class Im: The medical device has a measuring feature.
- Class Ir: The medical device is a reusable surgical instrument.
Is Nasal Spray considered a medical device?
In the case of a nasal spray, for example, making simple formulation changes ensured that the device acted as a mechanical barrier against airborne pathogens and allowed the spray to be classified as a medical device.
What is a medical device accessory?
What is a medical device accessory? An accessory is a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. A parent device is a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.
What is the difference between Class IIa and IIb?
Class I: A medical device with low risk. Class IIa: A medical device with low to medium risk. Class IIb: A medical device with medium to high risk. Class III: A medical device with the highest possible risk.
What are Class I II and III medical devices examples?
There are 3 classes of medical devices:
- Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
- Class II devices are intermediate-risk devices.
- Class III devices are high-risk devices that are very important to health or sustaining life.
What is Annex VIII?
Annex VIII to the CLP Regulation has provisions on the information provided on the concentration of mixture components (substances or mixture in mixtures). Different provisions apply to hazardous components considered of major concern and to other hazardous components and components not classified as hazardous.
