M
mylene
I am quite new in the field and would like to make sure I understand a bit more the process behind marketing a new class I medical device, to be sold on its own but to be used with our current Class IIa medical device already marketed in the EU.
So, we are planning to market a new accessory in the EU. It is a medical device class I, to be sold on its own. It is a single-use mouthpiece that goes with our current medical device class IIa. It would be a replacement option to our current reusable/washable mouthpiece.
What would be the regulatory route to compliance?
1. Isn’t obtaining the pre-market notification (1st Notification to the EU Competent Authorities) the first step to market the filter-mouthpiece? Then we can put the CE mark on it and we can sell it on its own or as an accessory, right?
2. Does this Notification need to be done through our ECrep or it can be done directly to the EUcompetent authority?
3. If the mouthpiece is made by another company, and we will be the Own brand labeller, which documents need to be gathered to show the EC-rep?
a. They have 13485(excluding the design part) and annex V.3 certificates, so do we need a Technical file? If they have taken this route to compliance, do they have and essential requirement checklist?
b. Product specifications?
c. Our DOC and their DOC?
d. Do we need, in addition to our label, to have their labels (for mean of comparison and to show the similarities between our labels and theirs)?
4. Would we need to do a change notification to our NB for our current class IIa device that will be used with this new single use mouthpiece as a replacement option to our current reusable/washable mouthpiece? We tend to think that this would not justify a change notification.
I know it’s a lot of questions… any parts of answer would be most welcome.
Thanks in advance
So, we are planning to market a new accessory in the EU. It is a medical device class I, to be sold on its own. It is a single-use mouthpiece that goes with our current medical device class IIa. It would be a replacement option to our current reusable/washable mouthpiece.
What would be the regulatory route to compliance?
1. Isn’t obtaining the pre-market notification (1st Notification to the EU Competent Authorities) the first step to market the filter-mouthpiece? Then we can put the CE mark on it and we can sell it on its own or as an accessory, right?
2. Does this Notification need to be done through our ECrep or it can be done directly to the EUcompetent authority?
3. If the mouthpiece is made by another company, and we will be the Own brand labeller, which documents need to be gathered to show the EC-rep?
a. They have 13485(excluding the design part) and annex V.3 certificates, so do we need a Technical file? If they have taken this route to compliance, do they have and essential requirement checklist?
b. Product specifications?
c. Our DOC and their DOC?
d. Do we need, in addition to our label, to have their labels (for mean of comparison and to show the similarities between our labels and theirs)?
4. Would we need to do a change notification to our NB for our current class IIa device that will be used with this new single use mouthpiece as a replacement option to our current reusable/washable mouthpiece? We tend to think that this would not justify a change notification.
I know it’s a lot of questions… any parts of answer would be most welcome.
Thanks in advance