CE-Mark regulatory advice - US based Organization

[asantcom]

Looking for some regulatory advice. We are trying to get CE mark for a class 2b device, we are US based. We are the legal manufacturer and do not have a QMS. Our real manufacturers are ISO 13485 certified.

Do we need to have a QMS in place before trying for CE mark?

 

[Zero_yield]

I would think it would be very difficult to sell in the EU without a QMS (unless I'm misunderstanding and you wouldn't legally be considered the manufacturer). Per EU MDR:

"The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the devices concerned."

"‘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 trade mark;"

And from the European Medicines Agency:

"Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.

"The conformity assessment usually involves an audit of the manufacturer's quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device."

Emphasis mine.

 

[DSurber]

Ditto Zero yield - Based on my MDR audit experience with a company in a similar situation (no own manufacturing), there’s no chance of certification w/o a QMS. On the bright side, you can leverage your CM’s procedures for portions of it.

 

[asantcom]

Ditto Zero yield - Based on my MDR audit experience with a company in a similar situation (no own manufacturing), there’s no chance of certification w/o a QMS. On the bright side, you can leverage your CM’s procedures for portions of it.

Thank you! So, best would be to carve out a QMS system then shoot for CE mark?

 

[asantcom]

I would think it would be very difficult to sell in the EU without a QMS (unless I'm misunderstanding and you wouldn't legally be considered the manufacturer). Per

"The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the devices concerned."

"‘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 trade mark;"

And from the

"Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.

"The conformity assessment usually involves an audit of the manufacturer's quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device."

Emphasis mine.

Thank you! So, best would be to carve out a QMS system then shoot for CE mark?

 

[Zero_yield]

I'm not a CE mark expert, but that would be my recommendation from what I'm reading. I work for a company that maintains a CE mark on the products I'm involved with, and we have a QMS.

 

[asantcom]

I'm not a CE mark expert, but that would be my recommendation from what I'm reading. I work for a company that maintains a CE mark on the products I'm involved with, and we have a QMS.

Makes sense. Thanks again