An update to the Manual on Borderline and Classifications under the MDR and IVDR has been published. The last update, version 2, was issued in December 2022, and since then has been updated to include the following devices: Root canal irrigation solutions, Temperature sensors embedded in orthopaedic devices for compliance tracking, System intended to produce sclerosing foam, n-butyl-2-cyanoacrylate based adhesives, Custom-made cranial implants. The recommendations from the manual can be found below.
Root Canal Irrigation Solutions
These devices usually contain a substance NaOCL or CHX which are substances that have antimicrobial properties. Both of these substances are considered to be a medicinal products with known pharmacological effects documented in literature.
If the manufacturer can demonstrate that the principal mode of action is the rinsing and the irrigation so that the solutions remove debris and necrotic tissues (mechanical action), the irrigating solutions fulfil the definition of medical device.
Referencing the MDCG guidance 2022-5, the manual suggests, scientific evidence, and not claims, is the only route relevant for the determination of pharmacological action. This would mean that, unless the manufacturer can provide robust scientific evidence that NaOCl or CHX in the irrigating solution has no antibacterial or antiseptic action in or on the human body or its constituents, using suitably scientifically rigorous tests, root canal irrigating solutions containing NaOCl or CHX should be classified as class III per rule 14 of Annex VIII to the MDR.
Temperature sensors embedded in orthopaedic devices for compliance tracking.
These devices are temperature sensors that are intended to be embedded in orthopaedic devices and tracks the use of the orthopaedic devices. The manual states that this should not be considered as a medical device, or an accessory to a medical device as the sensor itself does not specifically and directly assist the medical functionality of the orthopaedic device, furthermore, the orthopaedic device can function without the use of this temperature sensor.
System intended to produce sclerosing foam.
The system is intended to produce sclerosing foam for varicose veins treatment. Such devices usually consist of 2 products to be used in combination, a sterile single use mixing capsule filled with air and a reusable digitally programmable electronic stirrer. Such systems are intended to produce the sclerosing foam, which is considered a medicinal product, and which is going to be introduced to the body at a later stage via a syringe. In the case that the system itself, nor the capsule or stirrer administer the foam directly to the patient, the manual states that in this case, the device does not meet the definition of a medical device. In the case that the manufacturer include a CE marked syringe as part of the system, then the system would meet the definition of a procedure pack as stated in Article 22 of the MDR.
n-butyl-2-cyanoacrylate based adhesives.
These products are n-butyl-2-cyanoacrylate (nBCA) based adhesives that close the treated vessel via an adhesive seal. It has been seen that different manufacturers would classify this device based on the time of degradation of the embolizing agent.
Taking a look at Rule 8 (indent 3) of Annex VIII, there is no mention of the time of absorption, and due to this, the manual suggests that such devices would be classified as a Class III devices.
Custom-made cranial implants.
These devices are custom made implants that are intended to replace parts of the skull that have been injured with the ultimate aim to protect the brain. As such, these devices are intended to be used in direct contact with the central nervous system. Due to this, the manual states that this device should be classified as a Class III medical device under Rule 8, indent 2 of Annex VIII of the MDR.
Version 3 of the manual can be accessed using the following link
