ISO 13485 mandatory for a factory making Medical Devices for EU?

ugecha

Starting to get Involved
#1
Hello, my question is regarding MDD and EN ISO13485.
Our company holds MDD Annex 2 and EN ISO13485 certification. We sell our medical devices under our own name. That means we are legal manufacturer.

Now we are planning to let other company, which is not outside our quality system, makes our products for EU countries. They only have ISO 9001 certification.

Here are my questions are

1. Is the EN ISO 13485 compulsory for a factory to make any medical devices for EU?

If mandatory,

2. Will you give me rational for that? (eg. MDD… MEDDEV…)

3. Is it mandatory for all classes and for all types ?
Even for class 1 or simple accessories?

if not mandatory,

4. Even if EN ISO 13485 is not mandatory, is there any other requirements applied to them?

Thank you for your help so much.
 
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Marcelo

Inactive Registered Visitor
#2
Hi

Standards in the EU are not mandatory, only the easiest way to gain presumption of compliance.

1- No (so there´s no answer to 2 and 3)

4 - not sure if I understand the question. There´s quality system requirement in the directives (for example, the full quality assurance route of annex 2) which you need to comply with, and you may gain presumption of conformity if you use the harmonized standard.
 
Last edited:
J

Jagoda

#3
I is not necessary. In accordance to Dir 93/42 manufacturer should have for medical devices class I, appopriate technical file and some procedures (Vigilance, PMS, Risk menagement, CAPA, identification and traceability (see annex VII) for other class appropriate QMS have to be reviewed by notified body during audit conformity of the product.
Directive 93/42 does not indicate a particular standard (9001, 13485, or other).
I know from our auditor that certification of ISO 9001 or ISO 13485 is not necassary for medical device manufacturer.
 
J

Jagoda

#4
ad point 4: you can estabilish your own QMS (see annex II point 3.2) which takes into account appropraite harmonized standards, low acts and additional your requirements. Auditor would check it during:" Audit on assessment of QMS compliance to Council Directive 93/42/EEC. Conformity assessment procedure: annex XXX
 

ugecha

Starting to get Involved
#5
Thank you for your help, everybody.
I understand ISO13485 is not mandatory for the factory, which I mentioned above. Also notified body does not come to audit because their products are CLASS 1 devices.
However I just wonder why a factory with no certification such as ISO neither 13485 nor 9001 is allowed to make a medical device (even Class 1) and no audit at all. Is it sound a bit dangerous?
 

Marcelo

Inactive Registered Visitor
#7
I understand ISO13485 is not mandatory for the factory, which I mentioned above. Also notified body does not come to audit because their products are CLASS 1 devices.
However I just wonder why a factory with no certification such as ISO neither 13485 nor 9001 is allowed to make a medical device (even Class 1) and no audit at all. Is it sound a bit dangerous?
The basic idea of regulatory systems is that lower risk devices needs lower regulatory requirements.

Also, please do not confuse being in conformity with third party conformity assessment.

You can be in conformity without a third party coming and verifying if youo are in conformity.

This is the case for lower risk device in the EU, you need to comply with the requirements, but nobody will go there and check (unless there´s a problem).
 
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