Is it mandatory to obtain ISO13485 certificate prior to CE marking?

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R

RA_QA_Expert

Starting to get Involved
#2
#2
Hi, the certification is voluntary.

The certificate is usually requested by customers or national authorities during registration processes in non-EU countries.

For EU and CE marking, you need to meet MDD/MDR requirements relating the QMS. You should follow ISO13485, but certification is not requesred.
 
A

Aidan Madha

Registered
#3
#3
RA_QA_Expert said:
Hi, the certification is voluntary.

The certificate is usually requested by customers or national authorities during registration processes in non-EU countries.

For EU and CE marking, you need to meet MDD/MDR requirements relating the QMS. You should follow ISO13485, but certification is not requesred.
Click to expand...
Thank you! Your answer is very helpful :)
 
I

iparlatore

Registered
#4
#4
Yes, it is not mandatory, but to obtain the CE certificate from a NB they will want to see evidance of your QMS. If it not ISO 13485 certified, you will have to convince them that your QMS is equally good to that standard or better. It is very hard to achieve this way, the easier way is to get ISO 13485 certified.
 
S

Sicco

Involved In Discussions
#5
#5
iparlatore said:
Yes, it is not mandatory, but to obtain the CE certificate from a NB they will want to see evidance of your QMS. If it not ISO 13485 certified, you will have to convince them that your QMS is equally good to that standard or better. It is very hard to achieve this way, the easier way is to get ISO 13485 certified.
Click to expand...
Wrong!
You are not right that ISO 13485 is mandatory as RA_QA_Expert has mentioned above it is voluntary but you have to prove you fulfil requirements of MDD/MDR on your quality system and it is more easier if you have certification according to the standard.
 
C

Cari Spears

Super Moderator
Staff member
Super Moderator
#8
#8
Sicco said:
Wrong!
You are not right that ISO 13485 is mandatory as RA_QA_Expert has mentioned above it is voluntary but you have to prove you fulfil requirements of MDD/MDR on your quality system and it is more easier if you have certification according to the standard.
Click to expand...
Starting a reply with "Wrong!", is not going to be well received, even if someone is mistaken.
 
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