New Product Essential Requirements Cheat Sheet

K

katastic2908

#1
Hello,

I could use some help. I am reviewing one of our Essential Requirements Checklists for the anticipated release of a new product. I am having a dickens of a time making sure the standards they referenced can be used to show presumption of conformity for the sections they referenced them in. Besides checking in the annexes of each standard for their applicability is there some sort of cheat sheet that lists the standards and what what parts of the Essential Requirements they can be used for presumption of conformity? Something like this has to exist somewhere.

TIA
 
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Jean_B

Trusted Information Resource
#4
Hello,

I could use some help. I am reviewing one of our Essential Requirements Checklists for the anticipated release of a new product. I am having a dickens of a time making sure the standards they referenced can be used to show presumption of conformity for the sections they referenced them in. Besides checking in the annexes of each standard for their applicability is there some sort of cheat sheet that lists the standards and what what parts of the Essential Requirements they can be used for presumption of conformity? Something like this has to exist somewhere.

TIA
Assumptions:
The format is not in question, as you are reviewing a checklist which already contains standards. You want to determine two things:

1. Are the listed standards applicable?

2. Do I have all standards that need to be applied to prove presumption of conformity.

Essential requirements is the European Term (and you are in the EU Regulations forum), so I am assuming that you are only looking at Europe. As for base, the MDD is settled while the MDR still needs all of the explicit support documentation to be generated, so everything is MDD focused.

Closing the assumptions bit.

Whether a standard is applicable is determined from the scope in the standard versus the product.

Whether it is valid for presumption of conformity is based on presence in the harmonized standards list: Medical devices - European Commission

To what clauses (and extent) it applies can usually be derived from each standards Z-annex if present (only in EN editions).

Now this isn't foolproof (not all standards have the necessary information) so a high-level connection between MDD clauses and standards is specified in ISO 16142-1:2016 (for non-IVD; assumption again).

Expert interpretation is still necessary, but a good Regulatory and Engineering team should be able to work from this.

I will not provide it in full, but as the format may be pertinent to your needs a (trivial) sample is attached (can a moderator please check whether this is in-line with the copyright policy?). This is not available in the ISO OBP.
.
 

Attachments

Marc

Fully vaccinated are you?
Leader
#5
I have checked the attached graphic for copyright issues. It is so short that it is not a problem.
 

Highground

Involved In Discussions
#6
Hello,

I could use some help. I am reviewing one of our Essential Requirements Checklists for the anticipated release of a new product. I am having a dickens of a time making sure the standards they referenced can be used to show presumption of conformity for the sections they referenced them in. Besides checking in the annexes of each standard for their applicability is there some sort of cheat sheet that lists the standards and what what parts of the Essential Requirements they can be used for presumption of conformity? Something like this has to exist somewhere.

TIA
Engineering completes an applicable standard document first, then I fill in the essential requirement list with those that apply. They are quite long documents, a lot to review to ensure that I put the relevant standards and clauses, plus the supporting evidence, but it works.
 

Avraham Harris

Involved In Discussions
#7
... is there some sort of cheat sheet that lists the standards and what what parts of the Essential Requirements they can be used for presumption of conformity? Something like this has to exist somewhere.

TIA
I found the attached guidance from the Irish HPRA. I did not like everything I saw on the Essential requirements checklist section, though some out of date standards may be there because doc. is from 2009(?). Also am not sure they are correct that regulation should be quoted in ER Checklist in addition to standards. The question being addressed by Checklist is How is compliance to regulation being demonstrated. Another regulation or directive would not seem to be relevant here.
 

Attachments

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