CE Marking Basics - Medical Laser - Compiling the Technical File

A

azaplas

#1
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!
 
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V

Vitali57

#2
Re: CE Marking question, I am new to Regulatory

2 things...

1. Who was the notified body for your "old" medical laser? Can you use them again? May save you some money?

2. Have you checked the CE marking newsgroup?
 
R

Roland Cooke

#3
Re: CE Marking question, I am new to Regulatory

The DoC does not actually need to list your Notified Body.

After all if you have a Class I device you still need a DoC (and a technical file) even if you won't have a NB.


The DoC is a legal declaration(!) that your company has met its obligations under the relevant legislation. So strictly speaking your declaration should be made against the specific medical device regulations of the (European)countries into which you sell (albeit) no-one tends to mind if you claim compliance to the MDD instead.
So unless the country law says you must name the Notified Body in your DoC...you don't have to.

There was a NB consensus statement made years ago on the content of a DoC, I'll see if I can find it over the next few days.

In the meantime, if you need any guidance that you can't post here please feel free to send me a PM.
 
A

azaplas

#4
Re: CE Marking question, I am new to Regulatory

Hi there, thank you for your responses! In response to vitali57:
1. We are CE marked by SNCH (CE 0499). I am planning to use them for our new laser, I'm just not sure what I need to submit to them to see if we can get the CE on the new laser.
2. I haven't checked the newsgroup, that will be another place I look! Thanks.

Roland Cooke:
Thanks for the clarification on the Declaration of Conformity. Another question about the NBs and the technical file. A lot of the sections in the technical file refer to the NB (such as something along the lines of "we will maintain all documents related to the Notified Body/Authorized European Rep. for 15 years") and we link to another file that lists the Notified Body. Is it ok to link to the Notified Body file that we are applying to receive a CE mark from but aren't officially certified by yet?

Thank you both for your help!
 
T

temujin

#5
Re: CE Marking question, I am new to Regulatory

Hi,

See the attached file. I think that is the consensus statement Roland Cooke was referring to. There is one chapter regarding the recommended content of the declaration of conformity.

The "Blue Book" also has some good basic information on the topic.

I think at least if you use the "Full Quality System Assurance" route to conformity, it is normal to list the NB that did the quality system assurance.

regards

t.
 

Attachments

S

SteveK

#6
Re: CE Marking question, I am new to Regulatory

azaplas,

I might be missing something here, but if you do go (or already have gone) the “Full Quality Assurance System” route (Annex II), which would require “Document Control”, “Control of Records” etc procedures (to meet ISO 9001/13485 requirements), why have any reference to the notified body in the documentation (other than the reference number on the CE mark itself e.g. on the labelling and their name on the DoC)? The document related procedure(s) should indicate retention times in line with ISO 13485 (section 4.2.4) – again why reference the name of the notified body, they issue the certification, it’s your documentation. If you have completed all the technical documentation for the new laser i.e. comply with appropriate standard(s), conducted MDD checklist, design/manufacturing details in place, completed risk assessments (ISO 14971), clinical evaluations etc and do have a “Full Quality Assurance System”, I believe you would have the right to apply the CE mark now (if the current certification indicates the family of devices i.e. medical lasers)! Though notifying the NB of your intention would be the right thing to do (technical file audit?). I would ask their advice in any case. I repeat this would only apply if you have already gone the Annex II route, since it having the system in place, and this having been audited, is the important thing. The DoC could then include the current and new model references. Anyway that is my take on the matter, since it what I have in place for our Class IIa/IIb devices (which does include electrical items).

Steve:rolleyes:
 
R

Roland Cooke

#7
Re: CE Marking question, I am new to Regulatory

Hi,

See the attached file. I think that is the consensus statement Roland Cooke was referring to. There is one chapter regarding the recommended content of the declaration of conformity.

The "Blue Book" also has some good basic information on the topic.

I think at least if you use the "Full Quality System Assurance" route to conformity, it is normal to list the NB that did the quality system assurance.

regards

t.
Thanks Temujin, S/01/99 does give a reasonable list of what should be included in a DoC, and whilst it doesn't say that the NB should be identified, I would agree with you and Steve. that it is typically included.

Regardless of the certificate scope, whether or not you can "automatically" market the new laser really depends on how similar the product is to your existing approved models. Unless it is very similar you may well need to make an application to your NB.
 
A

azaplas

#8
Re: CE Marking Basics - Laser - I am new to Regulatory

tmujin and stevek, yes we are doing the full quality system assurance route (annex II). thanks for the DoC chapter link too!

I talked to my authorized european rep., and he said to "prepare a declaration of conformity that describes the product, names the Notified Body, names us as your AR, and gives the classification number. DO NOT SIGN. This should be part of the technical file but be annotated "not to be signed until Notified Body Certification is received"".
i think that would be the right thing to do for now.

stevek, yes we do have SOPs for document control and control of records. in the paper form of our technical file we don't actually reference the actual NB, we just say NB. But in the electronic form, the NB links to a document that lists SNCH (our NB for the old laser). I'm not sure why the electronic one links... maybe it was just for our internal reference (I'm using the old technical file as a template for the new one).

and another really really really general question: the device master record and the design history record need to be compiled first before submitting the technical file for NB review?

Thanks all for your responses!
 
R

rach14

#9
Re: CE Marking Basics - Laser - I am new to Regulatory

our company's product is classified as IIb also -- for our conformity assessment, with regards to the DoC, our notified body requested a draft of the DoC -- technically it could not be signed and dated by the company's rep (generally, for us, the Management Representative) until after receiving the actual CE marking certificate.

As for DMR, DHF, etc -- those are requirements under FDA's QSR (21 CFR Part 820) and do not directly apply to the Tech File, although some items may overlap. Annex A of ISO 14969 has a table that breifly outlines the similarities.
 
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