Class I Medical Device Requirements - Annex VII of the Medical Devices Directive

W

welshery

#1
Dear All

I have been asked to establish the requirements for CE marking a Class I medical device. Am I right in thinking that I only need to follow Annex VII of the medical devices directive or do I also have to answer all the statements in the essential requirements section too?
Many thanks in advance of your help. :bigwave:
 
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sreenu927

Quite Involved in Discussions
#2
Hi Welshery,

As per the MDD directive, you need to compile a Technical File with all the contents inside, one of which is Essential Principles Checklist. You need to do an assessment of the checklist, based on the applicability and reference relevant test reports/documents and applicable standards.
Annex VII is Declaration of Conformity,which is also a must to all devices intend to market into EU.

So for your case, u must have a technical file and EC DoC to be prepared and submitted to your EU Authorised Representative (EC REP). He, on your be-half will submit the RG Form3 and EC DoC to the National Competent Authority(based on his location in EU) to register your Medical device and also notifies to other EU countries, where you intent to market, provided the translation of labeling is adequate.

A copy of technical file should be provided to EC REP.

Hope this helps!

Regards,
Sreenu
 
W

welshery

#3
Hi Sreenu, thank you so much for your reply, much appreciated. We are actually based in the UK, so I assume we do not need an Authorised Representative and can just deal with the Competent Authority ourselves. Can you tell me what an RG Form3 is please. We intend to market the product all over the world starting though in Europe. Thanking you.
 

sreenu927

Quite Involved in Discussions
#4
Hi Welshery,

I realized your presence (in UK) after submitting the reply post. So directly with MHRA-UK, you can register your product by submitting the RG3 Form for IVDs.
For medical devices, it is RG2 Form, which is as attached and can also be obtained from MHRA website.

Regards,
Sreenu
 

Attachments

W

welshery

#5
Yes, I have just been looking on the MHRA website and have downloaded quite a few documents. Thank you once again. :thanx:
 

thisby_

Involved In Discussions
#6
I have a quick question, not directly related with this thread but maybe you can answer me.
If I am an US company (manufacturer) with an authorized representative in italy and want to register my medical device class I to MHRA can I do it or the authorized representative needs to be located in UK?

Thank you in advance!

Emilia
 

sreenu927

Quite Involved in Discussions
#7
Hi Emilia,

Your Authorised rep can register your product with Italy Ministry of Health and subsequently, notify to UK (and also to other EU countries, based on the available translations of labeling).

In EU, the product will be registered at the place of EC REP and then can send notification to all other EU Countries and can sell in those registered and notified EU COuntries.

Hope this helps!

Regards,
Sreenu
 
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