Home / ISO 13485 & EU MDR / Medical device classification
mohamed mostafa Created: Nov 19, 2020 Last commented: Nov 20, 2020
Now we registering a new product, indicated to aid in weight management in overweight and obese adults(inside each capsule the two ingredients form a three-dimensional hydrogel matrix. once in the stomach, the capsules break apart, exposing the matrix to water. each of hydrogel cells can absorb up to 100 times its weight, growing in size to occupy space in the stomach)
our marketing authorization asks for ISO 13485 and CE but after reviewing the scope of iso 13485 and the MDR, I can't classify this product under any rule.
kindly advise, is this product consider a medical device?
According to the MDR 2017/745, Article 2 – Definitions, medical device is
providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.During the definition process the main question is what is the intended purpose of the medical device. If you can state that your device has the intended purpose within the rules stated above, then you can state that it is a medical device.
If you look through the Annex 8 – Classification rules, in my opinion, you need to look if the following rules are applicable for your device:
class I if they are intended to be used as a mechanical barrier, for compression, or for the absorption of exudates
class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent
class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane, and
class IIa in all other cases.This rule also applies to the invasive devices that come into contact with injured mucous membranes.
class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose
class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body
class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities, and
class IIb in all other cases
EU MDR Article 2 – Definitions - https://advisera.com/13485academy/mdr/definitions/
EU MDR Annex 8 – Classification rules - https://advisera.com/13485academy/mdr/classification-rules/
ISO 13485 for Class 1 FDA medical device