Good Morning Everyone.
I work for a small medical device company which markets Class II(US), IIb(EU), III(Can) Orthopedic implants. Recently, we revised our medical device reporting procedure only in focus of US (a decision tree which can help decide to report or not report). We also have instruments Class II(US), Class IIa(EU) that assist in the placement of implants into the patient's body. Obviously, these instruments are not essential to maintable human life.
My question here is do I have to report to FDA if an instrument (not the implant) if it is broken or cracked during the surgery (with the fact that it didn't interrupt the surgery)? So, if this happens in USA, it triggers Canadian Medical device Problem reporting by default if the product is sold in Canada.
Canada defines the medical device reporting more broadly.
A mandatory problem report is required under the Regulations for any incident involving a medical device that is sold in Canada when the incident:
• occurs either within or outside Canada;
• relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use (section 59(1)(a)); and
• has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so if it were to recur (section 59(1)(b)).
What about EU reporting?
i know this is too much to ask. But I would really really appreciate if everyone of your could share you thoughts (supported by regulatory statements).
Also, does someone have a MDR decision tree for EU and Canada?
Thanks,
Eric.
I work for a small medical device company which markets Class II(US), IIb(EU), III(Can) Orthopedic implants. Recently, we revised our medical device reporting procedure only in focus of US (a decision tree which can help decide to report or not report). We also have instruments Class II(US), Class IIa(EU) that assist in the placement of implants into the patient's body. Obviously, these instruments are not essential to maintable human life.
My question here is do I have to report to FDA if an instrument (not the implant) if it is broken or cracked during the surgery (with the fact that it didn't interrupt the surgery)? So, if this happens in USA, it triggers Canadian Medical device Problem reporting by default if the product is sold in Canada.
Canada defines the medical device reporting more broadly.
A mandatory problem report is required under the Regulations for any incident involving a medical device that is sold in Canada when the incident:
• occurs either within or outside Canada;
• relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use (section 59(1)(a)); and
• has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so if it were to recur (section 59(1)(b)).
What about EU reporting?
i know this is too much to ask. But I would really really appreciate if everyone of your could share you thoughts (supported by regulatory statements).
Also, does someone have a MDR decision tree for EU and Canada?
Thanks,
Eric.