A
Hi everyone, I'm new to posting on the forums, and new to Regulatory in general. Please forgive me if I ask some really really basic questions.
I've been asked to acquire a CE mark on my company's newest medical laser. According to MDD/93/42/EEC, the laser is classified as a Class IIb device.
1. We already have one of our other lasers that is CE marked by a notified body out of Luxembourg, and we are gearing up to have the new laser submitted for CE marking. What elements do I need to submit to the notified to issue it a CE mark?
2. I’m compiling the technical file for the new laser, but in doing so I noticed that our Declaration of Conformity has to list the Notified Body. But I don’t understand how we compile the technical file to include a Notified Body, when we don’t really have a notified body for this product yet?
Any help is appreciated, and again I apologize if these questions are way off.
Thanks in advance!
I've been asked to acquire a CE mark on my company's newest medical laser. According to MDD/93/42/EEC, the laser is classified as a Class IIb device.
1. We already have one of our other lasers that is CE marked by a notified body out of Luxembourg, and we are gearing up to have the new laser submitted for CE marking. What elements do I need to submit to the notified to issue it a CE mark?
2. I’m compiling the technical file for the new laser, but in doing so I noticed that our Declaration of Conformity has to list the Notified Body. But I don’t understand how we compile the technical file to include a Notified Body, when we don’t really have a notified body for this product yet?
Any help is appreciated, and again I apologize if these questions are way off.
Thanks in advance!