Can an EU established branch of a Swiss company become EU manufacturer?

[George1234]

Hi all,

Company A is an company and legal entity established in Switzerland.
Company A has established a branch in a European country (let's say the Netherlands), called company B.
Company B is not a legal entity itself but is registered in the chamber of commerce in the EU country where is established.

According to EU MDR, can company B (without being a legal entity) become an EU legal manufacturer of medical devices? or even an EU importer?

The manufacturer and importer definitions both state the term "any natural or legal person established within the Union" which confuses me.

Thank you.

 

[ChrisM]

..... and the definition of "legal entity" is what? If Company B is established in an EU country, is trading and had paid employees, doesn't that mean that it must be sufficiently "registered" to be a legal entity? What makes you think that it is not a "legal entity"?

 

[George1234]

ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/rules-lev-lear-fca_en.pdf

What makes me think that company B is not legal entity, are the Rules for legal entity published by European Commission.
According to that document, branches are not considered to be legal entities (page 7).

 

[ChrisM]

Those are the EU Rules for Funding and Tenders, which no doubt differ from the rules for medical device manufacturing.
MDR definition of Manufacturer:
"Manufacturer" means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
And the definition if Importer:
"Importer" means any natural or legal person established within the Union that places a device from a third country on the Union Market.

 

[Ed Panek]

“Established within the Union” must also mean a legal person in this context. Unless Company B obtains a full legal identity (i.e., incorporation papers, a CEO, etc.), it can’t hold these roles under MDR.

If we go back 10 years, accountability for product malfunctions in the EU was a significant issue. The MDR was partially developed to address this shortfall. If you make any money from the sale of this medical device, we want to know who you are.