Hello everyone,
Article 61 6(b) of the MDR defines in some implants are exempted from the clinical investigations list, such as dental braces, wires, etc.
The original text is as follows:
6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices
and class III devices:
(b) that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or
connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant
product-specific CS, where such a CS is available.
Since these products such as dental braces do not meet the definition of implants in Article 2(5) ‘implantable device’, whether this exempted list is not limited to " implantable devices"? Or I misunderstood the classification of products such as braces?
Article 61 6(b) of the MDR defines in some implants are exempted from the clinical investigations list, such as dental braces, wires, etc.
The original text is as follows:
6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices
and class III devices:
(b) that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or
connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant
product-specific CS, where such a CS is available.
Since these products such as dental braces do not meet the definition of implants in Article 2(5) ‘implantable device’, whether this exempted list is not limited to " implantable devices"? Or I misunderstood the classification of products such as braces?
