Hello
I'm not exactly sure what "medical application" there might be for storing a sample that will not be introduced to the human body, so I don't know if it would meet the definition of a medical device:
"
any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, - investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, - providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, ..."
You might also consider if it meets the definition of an in-vitro diagnostic device:
"
any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices; "
Some of the classification rules in Regulation (EU) 2017/746 sound like they could apply more easily to a laboratory freezer.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 25-Aug-2019 03:24
From: Anonymous Member
Subject: Classification of Freezer in EU
This message was posted by a user wishing to remain anonymous
Hello,
I am trying to understand a Freezer's classification in Europe based on its intended purpose.
Intended Use: -40°C Upright Laboratory Freezers, intended to preserve samples by storing them at operating temperatures between -10°C and -40°C.
The Freezers are intended for use:
- As a storage device in research use
- As a storage device in medical applications
Non-Intended Use: The Freezers are not intended to store samples that are re-introduced to the human body. The Freezers are not intended for use in classified hazardous locations and not to be used for the storage of flammable inventory.
Should i consider it as a Medical Device or Non-Medical Device in EU? If Medical Device, can it be classified as class I as per Rule No. #2 ("In all other cases, such devices are classified as class I.") of MDR? Please advise.
PS. The device is a class I medical device in USFDA.
Thank you.