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Class 2a Medical Device

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