May 18, 2018

EMERGO SUMMARY OF KEY POINTS:

  • A new version of the Manual on Borderline and Classification has been published.
  • The seven new positions do not contain surprises.
  • It appears the MDEG is not yet involved in device status or classification questions regarding the MDR or IVDR.

On April 23 2018 the European Commission published Version 1.19 of the Manual on Borderline & Classification. Following the release of Version 1.18 in December 2017 it appears the Medical Devices Expert Group (MDEG) on Borderline & Classification is quite active.

European Manual on Borderline & Classification of medical devices updates for May 2018In Version 1.19 of the manual, six product statuses and one classification have been added. The agreed understanding of the status as a medical device, according to the MDEG, does not reveal surprises:

  1. A rugby helmet is not a medical device, because prevention of an injury is not part of the definition of a medical device. Emergo would consider this Personal Protective Equipment (PPE) and it should be placed on the market in accordance with the PPE Directive 89/686 (EEC).
  2. An autopsy saw is not used on a patient or for the benefit of that specific person. Therefore it is not a medical device.
  3. Air cleaned by a UV flow germicidal lamp, intended to decrease the level of microbiological load in hospitals, is not a medical device or used as an accessory of a medical device. Therefore the UV lamp is not considered a medical device.
  4. A water filter, intended to clean water before it is used in wounds or for cleaning devices, is also not used in or on patients and therefore it is not considered a medical device. The filter by itself is not intended to enable a device being used in accordance with its intended use and therefore it should also not be considered an accessory.
  5. A bone void filler that creates a scaffold for new bone formation is considered a medical device, even if it is assisted in that function by animal growth factors. The growth factors are not the main intended mode of action. This is a Class III device according to Rule 8, 13 and 17.
  6. A product that mimics starch in food, which through several steps in the digestive system could lead to weight loss, has a metabolic mode of action. It is not considered a medical device. Emergo would consider this a food substance.

One classification has been added:

  1. Cryotherapy chambers are used to deliver intense cold (around -110 degrees Celsius) to the body for pain relief, limitation of oedema post-surgery, treatment of rheumatologic pathologies and muscular injuries and/or for reduction of inflammation. They are considered active therapeutic medical devices and therefore Rule 9 applies. With these extreme temperatures it is obvious the energy is supplied in a potential hazardous way. Therefore cryotherapy chambers are considered Class IIb medical devices.

So far the MDEG has not produced a position regarding products under the Medical Devices Regulation (MDR) or In-vitro Diagnostics Regulation (IVDR). However, we may soon see the first cases and it will be interesting to see how this will be dealt with.

For now Emergo has reviewed the above cases from the MDR perspective. It will not come as a surprise that the product status of these cases will not change under the MDR. The risk classes of the two recognized medical devices also appear to remain the same, although there is a minor change in the applicable rules. The bone void filler would be in Class III according to rules 8, 14 (similar to rule 13 MDD), 18 (similar to rule 17 MDD) and rule 21. Rule 21 is the new rule about substance based devices. Rule 9 remains applicable for the cryotherapy chambers.

Additional European medical device and IVD regulatory resources:

Author

  • Ronald Boumans

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