Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU)

[henry_fong168]

Hi all,

Our company uses contract manufacturers to produce medical devices and shipped to the US and Europe. Our contract manufacturers is currently the "Legal / Labelled manufacturer" as they have ISO13485 and CEs. Although we do not manufacture the products in our facility, we have now obtained the ISO13485 certificate.

We are also in the progress of obtaining CE Certificate (Annex V) for our products.

In this case, are our contract manufacturers still remain as legal / labelled manufacturers until we get our CE Certificates?

i.e. once we have obtained our CE certificate (having both ISO13485 + CE certificate on hand), then we will become the legal manufacturer and our company name will be shown on the product labels...and will take on more regulatory responsibilities...etc?

But until we get our CE certificate, our company is still not the legal / labelled manufacturer.

Looking forward to your comments!

Cheers

 

[Ronen E]

Re: Who is the legal / labelled manufacturer? (Contract Manufacturers shipping to the

Not sure I understand exactly what you are asking.

The entity which has it's name and address on the label needs an EC certificate for selling into the EU (unless it's a non-sterile non-measuring class 1 device). An ISO 13485 certificate is not mandatory although this is the straight forward way to achieve QMS compliance with the EU regulatory requirements (where they apply).

Only once you have the EC certificate and have complied with all other applicable MDD requirements you'll be allowed to put your name and address on the label and introduce the device's to the EU market as your own. At that point you will also assume full regulatory responsibility.