But if you want to be more specific, we can say that there are 3 sub-classes under class I. Access our compliance store to explore the range of product certification services we offer or have a look at our product compliance management system for enterprises. Non-active Medical d evices .  ±1%   ±1%  If more than one rule is applicable to the device, the rules resulting in the highest classification of the device shall apply. The manufacturers of such devices can choose one out of three possible CE marking routes. Measurement accuracy: There are four device classifications: – Class I – Class IIa – Class IIb – Class III. Medical devices class I have the lowest perceived risk. pacemakers, implantable infusion pump) are covered by a separate directive, the Active Implantable Medical Devices Directive. In case your product is in class IIb, similar to the procedures in class IIa, you will need a Notified body to assess your technical documentation for compliance with the Medical Device Directive. Medical Devices: How To Set Out A Good Design Verification Approach, compliance with the Medical Device Directive, How To Distinguish A Real CE Mark From A Fake Chinese Export Mark. Risk . LCD, four direction adjustable  As per MDR Article, 51 Medical Devices are divided into class I, IIa, IIb and class III, taking into account the intended purpose of the devices and their inherent risks. The MDD 93/42/EEC , Annex IX, rule 15 dictates: - All devices intended specifically to be used for disinfecting medical devices are in Class IIa. We at Clever Compliance, previously CECHECK, can answer all of your questions. M5 Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb. Many medical devices have a relatively short product lifecycle because they are being continually improved or replaced by newer products. For class IIa Medical Devices, the declaration of conformity is backed up by notified body assessment. Class Is: Produit de classe I distribué à l’état stérile; Classe Im: Produit de classe I avec une fonction de mesurage; Classe Ir: Produit de classe I qui est re-nettoyé pour être ré-utilisé; Et pour ces 3 sous-classes, un Organisme Notifié est nécessaire pour la certification. Classe IIa (risque potentiel modéré/mesuré), qui comprend par exemple les lentilles de contact, les appareils d’échographie, les couronnes dentaires ; Classe IIb (risque potentiel élevé/important), qui comprend notamment les préservatifs, les produits de désinfection des lentilles, White+Blue Depending on its Intended Purpose, a medical device may be classified as Class I (including Is & Im), Class IIa, IIb and III, with Class III covering the highest risk products. How they are classified depends on 23 rules that consider their function, the risk to patients and the manufacturer’s intended use. - The mode of action of a medical device should be clear and evidenced with appropriate data to confirm this mode of action. Similar products can be classified differently depending on the intended use and claims made for them. Features For instance, characteristics such as intended use, invasiveness, and local vs. systemic effects. Choose Conformity Assessment Route: refer the flow chart below. Medical devices are divided into four risk classes: I (Im, Is), IIa, IIb and III. Meaning, only products intended to disinfect medical devices will fall within the scope of the medical device directive. ±2% within 70%-100%, (<70% undefined) Compile the Technical File. Class IIa Medical Device CE Marking Class IIa Medical Devices are considered as medium risk devices compared to Class I type of Medical devices. 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