xcanals_tecno-med.es
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Dear all
as you know the EU definition of medical device is changed in the MDR 2017/745 and include now "products specifically intended for the cleaning, disinfection or sterilization of devices" as for example sterilizers.
As indicated in the last version of the MANUAL ON BORDERLINE AND CLASSIFICATION version 1.22 (05-2019) for the MDD "these do not fulfil teh definition of medical device or accesory".
Do you think that now does not fulfil the definition of accessory of a STERILIZER ?
‘accessory for a medical device’ means 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);
I see that no manufacturers are until now commercializating sterilization controls as BI, BowieDick, ... with CE mark, are all waiting the application date 26 may 2020?
as you know the EU definition of medical device is changed in the MDR 2017/745 and include now "products specifically intended for the cleaning, disinfection or sterilization of devices" as for example sterilizers.
As indicated in the last version of the MANUAL ON BORDERLINE AND CLASSIFICATION version 1.22 (05-2019) for the MDD "these do not fulfil teh definition of medical device or accesory".
Do you think that now does not fulfil the definition of accessory of a STERILIZER ?
‘accessory for a medical device’ means 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);
I see that no manufacturers are until now commercializating sterilization controls as BI, BowieDick, ... with CE mark, are all waiting the application date 26 may 2020?