Class IIa Medical Device
Class IIa medical device constitutes medium-risk devices such as orthodontic wires, surgical gloves, lancets, etc. For class IIa the declaration of conformity is backed up by notified body assessment. It hold a unique position within this classification system, embodying a delicate balance between innovation and patient safety.
Class iia medical device CE Conformity Assessment Route
- Declaration of Conformity as per Annex IV
- Affixing the CE mark as per Annex V
Class 2a Medical Device Examples
Class IIa medical device encompass a wide range of medical technologies, often involving devices that come into contact with the body for diagnostic, therapeutic, or monitoring purposes. Some examples of Class IIa devices include:
1: Non-invasive Blood Pressure Monitors: Devices that measure a patient’s blood pressure without penetrating the skin fall under this category. These monitors are commonly used in clinics, hospitals, and home healthcare settings.
2: Infusion Pumps: Infusion pumps are used to deliver fluids, such as medications or nutrients, into a patient’s body in controlled amounts. They are vital in various medical treatments.
3: Contact Lenses: Non-corrective and corrective contact lenses for medical purposes fall under Class IIa. These lenses can have various applications, such as therapeutic or cosmetic use.
4: Diagnostic Ultrasound Devices: Ultrasound devices used for diagnostic imaging purposes, such as obstetric ultrasound, are classified as Class IIa. They are crucial tools in prenatal care and diagnostics.
5: Dental Filling Materials: Dental products like dental fillings and crowns that are intended to be placed within the oral cavity fall under this category.
Consultants Roles and Responsibilities
It is a must to have experts on board who have previous experience with Class IIa medical device EU compliance and clinical evaluation for a successful outcome! Roles of I3CGLOBAL are as follows:
- Guidance and Technical File preparation
- Identifies test requirements and reviews the external reports
- Prepares Clinical Evaluation report as per Meddev 2.7/1 Rev 4.
- Prepares PSUR report
- Arranges Notified Body and coordinates with them till the issue of CE Certificate
- Arranges EU Representative from European Union
- Arranges Free Sale Certificate from European Union