Class I Medical Device - 1st notification and change notification

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


 

sreenu927

Quite Involved in Discussions
Hi Mylene,

Welcome to Cove:)

For Q1:
1. For Class I, you can opt for Annex VII Conformity route and with self-declaration CE Marking, you can sell in EU.
2. If you want to sell this new mouth-piece as a stand alone instrument, then based on the classification (Class I), then follow the Self-Declaration route and obtain CE Marking and sell. You need to have a Technical File and Declaration of Conformity to be prepared and submitted to EC REP.
3. If your new mouth-piece is an accessory, then add this accessory in the already marketed Class IIa product’s EC Declaration of Conformity and inform to your EC REP and NB of this change and update the Class IIa product’s Technical File. This may or may not require re-audit by your Notified Body. You need to assess and/or discuss with your NB.


For Q2:
Yes, everything has to go through EC REP. Directly, you can’t enter into EU market, unless you have office in EU. If you have office in EU, then one person with in the Company must act as your (SG location) EC REP and he on your be-half has to submit the DoC by filling appropriate forms and notify the Competent Authority.

For Q3:

As per EU regulations, if you are Manufacturer, (that means, who ever actually manufactures the product and the product label consists your address, you bear legal responsibility of complete product), then you need to obtain CE Marking based on it’s classification (in this case, as you mentioned as Class I; so Self-Declaration method) if you intent to sell as a stand alone instrument; otherwise it falls under Class IIa as part of the existing instruments’ accessory, which needs notification to your NB/EC REP and CA. Discuss with NB on re-audit with this change (supposedly significant change).

All it depends on the Contract agreement between both the parties.

Also check for the Own brand labeling Guidance doc as attached, and also search for similar threads in this forum.
http://elsmar.com/Forums/showthread.php?t=36488&highlight=brand+labeling

For Q4:
If replacement of accessory then, depending on the impact, you may or may not require NB audit. However, a significant change notification has to be raised and informed to your NB and EC REP and notified to the Competent Authority, as you are withdrawing one of the accessories and replacing with a new accessory.

Hope this helps.

There may be other replies from experts.

Regards,
Sreenu
 

Attachments

  • MHRA Bulletin 19 - Own Brand Labelling (1).pdf
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M

mylene

Thank you very much Sreenu.

1. Showing the manufacturer's certificates (already CE marked with the 13485 and the annexV.3 certificates) couldn't be a replacement for the Technical file, right?
I guess we have to gather those certificates, along with other documents that we managed to have from them to try to built a technical file as complete as possible?

Do we need "their" Declaration of conformity along with "our" declaration of conformity?

Do we need, in addition to our label, to have their labels (I read somewhere that they need to be similar, so for mean of comparison and to show the similarities, we would need to gave them their labels)?

Thanks
 

sreenu927

Quite Involved in Discussions
Hi Mylene,

Let us consider your's as Company A and the other as Company B.

If B has it's own ISO 13485 and EC Certificates, assuming A as legal manufacturer, you need to keep a copy of technical file and DoC; however as this (mouth piece) is forming as an accessory for Company A's Class IIa device, and assuming it is not sold as a stand alone product, then the risk classification of Company B's mouth piece will be changed to Class IIa and you need to update your (Comp A) technical file that is obtained from Company B's Technical File and Company A being the legal manufacturer.

So first try to figure out the relationship between Companies A &B through a contract agreement and come out with the roles & responsibilities such as Legal Manufacturer - OEM or Distributor - Manufacturer or anything else.

Once this is settled, then you can decide on pasting labels. If A is legal manufac, then A's label will be present.

Regards,
Sreenu
 
R

Raymond12

Hi All,

Does anyone have experience of change notification to global regulatory authorities.

The change is the company name for A to B, the devices registered are Class IIa, IIb and III devices. The markets I am enquiring about are -

USA (510k)
Brazil
South Korea (Class III)
Malaysia
Taiwan
Japan (Class III)
Iran
Portugal (Class III)

If anyone could help it would be greatly appreciated. Apart from the name change, nothing within the company is changing i.e. Quality System

Best regards,
Ray
 
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