K
katastic
Good Morning,
I am wondering if anyone out there can help me out. I work for a small Surgical Instrument company in Colorado. We just had a review of our Technical File by our Notified Body so we can self certify our Class Ins instruments. One the report given to us by our Notified Body, one of the findings was that we needed to add the "Lot" number symbol to our labels (I'm assuming along with the lot number of the instrument) However, I am trying to find out if this is a requirement for Class Ins instruments. All I can find or gather from the MDD is
13.3. The label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 (2) or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate;
(b) the details strictly necessary for the user to identify the device and the contents of the packaging;
(c) where appropriate, the word 'STERILE';
(d) where appropriate, the batch code, preceded by the word 'LOT', or the serial number;
It indicates "Where appropriate" but I have searched and searched to try and find what is deemed "appropriate" and I just need a reference to a applicable standard, that I can reference. I hope all that makes sense and I appreciate any help that can be given.
I am new to the world of Medical Devices, so I may be coming back with more questions.
thank you
I am wondering if anyone out there can help me out. I work for a small Surgical Instrument company in Colorado. We just had a review of our Technical File by our Notified Body so we can self certify our Class Ins instruments. One the report given to us by our Notified Body, one of the findings was that we needed to add the "Lot" number symbol to our labels (I'm assuming along with the lot number of the instrument) However, I am trying to find out if this is a requirement for Class Ins instruments. All I can find or gather from the MDD is
13.3. The label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 (2) or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate;
(b) the details strictly necessary for the user to identify the device and the contents of the packaging;
(c) where appropriate, the word 'STERILE';
(d) where appropriate, the batch code, preceded by the word 'LOT', or the serial number;
It indicates "Where appropriate" but I have searched and searched to try and find what is deemed "appropriate" and I just need a reference to a applicable standard, that I can reference. I hope all that makes sense and I appreciate any help that can be given.
I am new to the world of Medical Devices, so I may be coming back with more questions.
thank you