What is the difference between MDD Annex II, Sec 3 and ISO 13485 ?

Q

QA-RA Jones

#1
All:

I am trying to figure out the difference between an ISO 13485 (issued by US registrar) and Full Quality Assurance System (CE) Certificate based on Annex II, Sec 3 of the MDD 93/42/EC (issued by EU Notified Body). Before I joined the company they had ISO 13485, however let it expire since they received a Full Quality Assurance System Certificate from a NB (CE approval). We are a US based company.

Does anyone see any benefit to having both of these certificates? Aren't they just proving out the same thing (getting audited 2x for the same thing by different groups)?

I would love to hear some opinions and comparison facts on this topic.

(We are a medical device design and distribution company)

Thank you for any input!
 
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Marcelo

Inactive Registered Visitor
#2
Re: Full Quality Assurance System (CE Annex II, Sec 3) vs ISO 13485

An ISO 13485 certificate shows compliance with all requirements from ISO 13485. It?s usually not mandatory for anything.

A Full Quality Assurance System (CE) Certificate based on Annex II show compliance with Annex II only + Annex VII, which is a conformity assessment route for CE marking, and is mandatory for getting a CE marking (well, at least one of the routes is mandatory). Also, this does not show compliance with all requirements of ISO 13485.

If you don?t need to show compliance with ISO 13485 for anything, you really don?t need a ISO 13485 certificate.
 
S

Sarah Stec

#3
Re: Full Quality Assurance System (CE Annex II, Sec 3) vs ISO 13485

Short answer: ISO 13485 and the MDD Ann. II.3 aren't the same, so an ISO 13485 certificate issued by a US registrar isn't the same as an Annex II.3 certificate from an NB. So, they aren't necessarily proving the same thing. It sounds like they are, but they aren't. <Insert discussion about the purpose of ISO 13485 vs. the MDD here.> :popcorn:

You can find the differences and similarities between EN ISO 13485:2012 and the MDD by looking at the Z Annexes in the beginning of the standard. Make sure to use the harmonized standard version (the EN version) to get these informative annexes. In these annexes you'll find a table that shows the correspondence between each clause of the MDD Annex II.3 and EN ISO 13485 to show where they meet (or where they don't meet). Being the harmonized standard, it does show a presumption of conformity to the requirements in the MDD, but as you'll see in the Z Annex, there are still some regulatory requirements to fulfill.

Whether or not you need the two certificates is up to you and your business, and your customers. Most notified bodies can certify you to both ISO 13485 and the MDD in one audit, so you don't necessary need to go through two separate audits. However, sometimes a manufacturer's customers want to see the ISO certificate along with the CE certificate. Sometimes the manufacturer wants the ISO certificate for other jurisdictions aside from Europe. It depends on what your needs are. So if you've been using the CE certificate by itself and you haven't been audited to ISO 13485, and you don't feel a need to do so, then that's fine too.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Full Quality Assurance System (MDD Annex II, Sec 3) vs ISO 13485

All:

I am trying to figure out the difference between an ISO 13485 (issued by US registrar) and Full Quality Assurance System (CE) Certificate based on Annex II, Sec 3 of the MDD 93/42/EC (issued by EU Notified Body). Before I joined the company they had ISO 13485, however let it expire since they received a Full Quality Assurance System Certificate from a NB (CE approval). We are a US based company.

Does anyone see any benefit to having both of these certificates? Aren't they just proving out the same thing (getting audited 2x for the same thing by different groups)?

I would love to hear some opinions and comparison facts on this topic.

(We are a medical device design and distribution company)

Thank you for any input!
Let me take a wild guess on what happened:

When your NB audited you to annex II s. 3, they viewed your ISO 13485 certification, and since the normative content in ISO 13485:2003 and EN ISO 13485:2012 is the same, they ticked off your compliance for the clauses in s. 3 which EN ISO 13485:2012 covers (as listed in its relevant Z annex). They then proceeded to audit you to all the other clauses, and based on all that eventually certified you to annex II.

If you give up your ISO 13485 certification without coordinating your actions with your NB, you might have an issue during your next renewal / surveillance audit. On the other hand, it does make sense to consolidate your certifications - any NB could certify you to EN ISO 13485. I don't think that the total cost will be much bigger (unless you had a really good bargain with your US registrar or your NB will be greedy :)), plus, your certification interaction will be more streamlined and efficient. The NB audit might get longer but the US registrar's one will be eliminated.

Cheers,
Ronen.
 
Q

QA-RA Jones

#5
Re: Full Quality Assurance System (MDD Annex II, Sec 3) vs ISO 13485

This is all helpful. We do not have a lot of customer's that require the 13485, so I believe that is why it was dropped ( I was not around at the time this decision was made). I think if we ever needed to get 13485 again it would be pretty easy since we comply with FDA 21 CFR 820 and the MDD for CE marking.

Is there a comparison chart out there for 13485 vs MDD regulations? I have seen them for 13485 and 21 CFR 820, but not for the MDD 93/42/EC.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Full Quality Assurance System (MDD Annex II, Sec 3) vs ISO 13485

This is all helpful. We do not have a lot of customer's that require the 13485, so I believe that is why it was dropped ( I was not around at the time this decision was made). I think if we ever needed to get 13485 again it would be pretty easy since we comply with FDA 21 CFR 820 and the MDD for CE marking.

Is there a comparison chart out there for 13485 vs MDD regulations? I have seen them for 13485 and 21 CFR 820, but not for the MDD 93/42/EC.
As explained above, that chart is in EN ISO 13485:2012 annex ZB.

If you go for a MDD audit without any 13485 certification the audit might get longer and cost more. Just my :2cents:
 
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