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Compliance to EU Official Journal Harmonized Standards (MD/IVD products in EU)

QAengineer13

Quite Involved in Discussions
#1
I believe that the manufacturers marketing MD/IVD products in EU have to comply with the Directive/ regulation for which they need to exercise due diligence to demonstrate their compliance to the harmonized standards in EU official journal.

The challenge I am facing at work with the management team is that they fail to recognize that the particular standard requirements need to be met

To be more clearer about the situation here is an example IEC 62304 is adopted in the OJ and we need to demonstrate compliance is my view point but they say that these standards are not mandatory so we dont need to comply.

I need some guidance as to how to convince them and also some legal writing to show them that we need to comply to them or be able to demonstrate that we have used suitable alternate method. any input would be greatly appreciated!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Compliance to EU official journal harmonized standards

we need to comply to them or be able to demonstrate that we have used suitable alternate method.
This is correct, and essentially your management is right. There's no obligation to comply with harmonized standards.
 

QAengineer13

Quite Involved in Discussions
#3
Re: Compliance to EU official journal harmonized standards

Ronen,

Does that mean the company can market products into EU without complying to any standards in OJ?

Thanks
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Compliance to EU official journal harmonized standards

Legally, yes.
Practically it might no be the easiest / most efficient route.
 

dgrainger

Trusted Information Resource
#6
The requirement is that the device meets the relevant essential requirements as given in Annex I of the directives.
You can do this by use of Harmonized standards but the choice is yours.
 
R

ryannh

#7
as stated above your management is technically correct. Please find the attached link for the EU regarding use of harmonized standards.
I had this same misconception up until about a year ago.

http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

With that being said, using a harmonized standard is the easiest way to show compliance (IMO).

It will be interesting to see how this changes with the MDR and common specifications in the future.
 
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