Hello everybody!
I’m studying the new MDR for medical device and I have a question related to classification. One of the new rule introduced in the MDR is the rule 21 which includes substance based medical devices. If I well understood all these medical devices will be classified under rule 21 and the class of risk will vary depend on the product absorption.
Can you give me practical example for each risk class (IIb, IIa and III)?
I have a medical device (substance based) for the treatment of acidity and gastroesophageal reflux which acts in the stomach but is then evacuated through faeces. In which class does it fall?
I think class IIb, rule 21 but I’m not sure.
Thank you in advance!
I’m studying the new MDR for medical device and I have a question related to classification. One of the new rule introduced in the MDR is the rule 21 which includes substance based medical devices. If I well understood all these medical devices will be classified under rule 21 and the class of risk will vary depend on the product absorption.
Can you give me practical example for each risk class (IIb, IIa and III)?
I have a medical device (substance based) for the treatment of acidity and gastroesophageal reflux which acts in the stomach but is then evacuated through faeces. In which class does it fall?
I think class IIb, rule 21 but I’m not sure.
Thank you in advance!