Self Declaration for CE Class I, Non-Invasive Medical Device

T

topher4209

#1
#1
Forum,

First off let me say that this cove is awesome and helpful.
Now if I have classified my 3 product families correctly and they are Class I, rule 1 (non-invasive, without a measuring device) I can self declare my product. I have also built my Technical Files. What is the next step to self declare?

I have a lot of experience with the FDA CFR, but not CE so any help you be great.

:thanx:
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
topher4209 said:
Forum,

First off let me say that this cove is awesome and helpful.
Now if I have classified my 3 product families correctly and they are Class I, rule 1 (non-invasive, without a measuring device) I can self declare my product. I have also built my Technical Files. What is the next step to self declare?

I have a lot of experience with the FDA CFR, but not CE so any help you be great.

:thanx:
Click to expand...
Hi,

The MDD is your best friend. I recommend reading it cover to cover, excluding annexes II-VI (inclusive). For class I self-declaration follow annex VII.

Cheers,
Ronen.
 
T

topher4209

#3
#3
Thank you. Everything I search is pretty vague. But it gives me a direction.
 
Last edited by a moderator:
S

sreenu927

Quite Involved in Discussions
#4
#4
In short, as you already compiled a technical file, now draw an EC Declaration of Conformity as per the format. Release your Technical file per your document control process. From the released date/EC DoC signed date, you can manufacture your products and paste the label bearing CE Marking and the ECREP contact address, and start shipping to EU.
If you want to ship to non-English speaking EU countries, then you must translate your labelling into that corresponding language, before you ship to that country.

Regards,
Sreenu
 
T

topher4209

#5
#5
The country is Denmark. I thank you for the information. I love this site. I have been doing this for 12 years but CE is a mystery to me.
 
T

topher4209

#6
#6
European Authorised Representative Medical Devices

Again I love this site. I need an AR to call me back so I can class my product and move forward. As I stated on a deadline, and we are a small organization. I have contacted many AR's I need feedback please. :bigwave:

Warm Regards,

Christopher, CQE
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#7
#7
Re: European Authorised Representative Medical Devices

topher4209 said:
Again I love this site. I need an AR to call me back so I can class my product and move forward. As I stated on a deadline, and we are a small organization. I have contacted many AR's I need feedback please. :bigwave:

Warm Regards,

Christopher, CQE
Click to expand...
Hi,

You don't need an AR "to class your product". You classify your own product. You need the AR to register your class I with a Competent Authority. You also need an AR because the MDD requires that you have one if you don't have a place of business registered in a Member State. It's all in the MDD which is available to all, online, free of charge.

What feedback are you looking for?

Cheers,
Ronen.
 
T

topher4209

#8
#8
Re: European Authorised Representative Medical Devices

I thought I needed an AR to class in case my classification was incorrect. As I said I'm new to CE I have read everything this site as provided. I was under the impression that an AR still audits or overviews at least one of my 3 Technical files.

Thank you for the information.
 
Q

QualityGuy50

#9
#9
sreenu927 said:
In short, as you already compiled a technical file, now draw an EC Declaration of Conformity as per the format. Release your Technical file per your document control process. From the released date/EC DoC signed date, you can manufacture your products and paste the label bearing CE Marking and the ECREP contact address, and start shipping to EU.
If you want to ship to non-English speaking EU countries, then you must translate your labelling into that corresponding language, before you ship to that country.

Regards,
Sreenu
Click to expand...
I'd agree with this but add that registration with the Competent Authority of the country where the legal manufacturer is based is needed before affixing the CE mark and selling. There may be a small fee (a few hundred euro) for registration and periodic renewals depending on the Competent Authority.

The conformity assessment route followed will be Annex VII (self-declaration and registration with Competent Authority) provided the device is not provided sterile and does not have a measuring function.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#10
#10
Re: European Authorised Representative Medical Devices

topher4209 said:
I thought I needed an AR to class in case my classification was incorrect. As I said I'm new to CE I have read everything this site as provided. I was under the impression that an AR still audits or overviews at least one of my 3 Technical files.

Thank you for the information.
Click to expand...
Hi,

As above, everything basic that you need to know is in the MDD. It includes what the AR role is (and isn't). The AR is not supposed to audit or challenge your classification. In fact, they're not required to master classification or any other regulatory aspect except registration of class I devices and their post-marketing surveillance / vigilance obligations. Some ARs would have broad knowledge and would be able to consult, but this is not required by the MDD and is not what they're there for, in regulation terms. Your conduct regarding non-sterile non-measuring class I devices is mostly up to you. In higher classes the oversight lies with the NB.

It's good to read threads in Elsmar but IMO this should be in addition to the MDD, not instead.

Cheers,
Ronen.
 
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