MDR Medical Device Definition

European medical device manufacturer need to analyse whether their product is under scope of New Medical device regulation(MDR 2017/745) .

Compared with MDD, MDR Medical device definition extends its Medical device scope.

The following list shows the changes:

·       1.Implant and reagent are added

·       2. Prediction, prognosis and pathological process or state are added. Handicap is replaced with disability ,

·       3.in vitro examination of specimens derived from the human body, including organ, blood and tissue donations is added

·       4.Devices for the control or support of conception and products specifically intended for the cleaning, disinfection or sterilisation of devices  are added

·       5. The products without an intended medical purpose listed in Annex XVI and Medical Device Accessories also need to comply MDR

·       Medical Device Definition as per Article 2

‘medical device’ means 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, 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. 

The following products shall also be deemed to be medical devices:

 — devices for the control or support of conception; 

— products specifically intended for the cleaning, disinfection or sterilisation of devices 

accessory for a medical device’:

an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

Click below link to know more about IVDR device defintion:https://meddev-info.blogspot.com/2021/03/ivdr-definition.html

Source: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC