Regarding Essential Requirements Checklist

anbknaga

Starting to get Involved
#1
Hey, new user here and new to medical field as well.

So I have a question regarding the various essential requirements checklist examples i saw online for MDD 93/42/EEC.

Is the ER Checklist official document?

If not, who keeps the checklist updated?

My main question:

Why cant i find the ER checklist anywhere in CE EU website but i can find it in the Australian government official health website?
 
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pkost

Trusted Information Resource
#2
the checklist is not an official document, it has just become a defacto standard way of communicating a manufacturers compliance with the essential requirements

It is the responsibility of the manufacturer to keep it up to date; although it rarely changes as the content is pulled word for word from Annex I of the directive
 

anbknaga

Starting to get Involved
#3
the checklist is not an official document, it has just become a defacto standard way of communicating a manufacturers compliance with the essential requirements

It is the responsibility of the manufacturer to keep it up to date; although it rarely changes as the content is pulled word for word from Annex I of the directive
Ok but why it is not shown in CE EU official website but i can see that in AU or CA website?
 

pkost

Trusted Information Resource
#4
It is not a requirement in the EU to use the essential requirments checklist; the only requirement is that you demonstrate compliance with the essential requirements documented in Annex I. Therefore why would you expect to find it on the EU website?
 

Ronen E

Problem Solver
Moderator
#5
It is not a requirement in the EU to use the essential requirments checklist; the only requirement is that you demonstrate compliance with the essential requirements documented in Annex I. Therefore why would you expect to find it on the EU website?
It's also not an Australian requirement, just a format preferred by TGA auditors. The TGA template is provided as a courtesy.
 
T

tigerdee

#6
Does anyone on this thread have a copy of the annex 1 checklist revised for the new eu mdd revision??
 

Ronen E

Problem Solver
Moderator
#7
Does anyone on this thread have a copy of the annex 1 checklist revised for the new eu mdd revision??
Hi tigerdee, welcome to the discussion :bigwave:

Not sure what you refer to by "the new eu mdd revision" - do you mean the MDR, published 5/5/2017? If so, I'm not yet aware of a checklist template for its Annex I requirements. However, it shouldn't be difficult to create one, based on whatever existing template you have for the "old" (current) MDD ERs. The MDR is available free of charge on the Eur-Lex website.
 

Jane's

Involved In Discussions
#9
Apologies for a semi-related bump.

We historically had records retention time set to three years or the lifetime of the device which ever is longer, while MDD requires minimum of 5 years. This is Annex II or V requirement (not Annex I) so I was wondering how do people ensure they satisfy all the MDD (soon to be MDR) requirements, not just the essential requirements. Does it make sense to include Annex II checklist to the essential requirements checklist? I should also add that we are Class I self-declared, so we were not audited by a notified body.
 
E

EthanLoh

#10
Australia Essential Requirements is differ from EU Essential Requirements. However there are a MRA between and Australia and EU.

TGA is a notified bodies (NB 0805) under EU.:bigwave:
 
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