OEM and PLM under MDR

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Shaka256

Hi again, not sure what's the best way for conformity assessment in case of OEM and PLM:
Company A: designs and produces many medical devices
Company B: asks company A to make small changes to some of the products and label it under company B name (it is identified as the manufacturer).

Now company B wants to get a CE certificate under the MDR- is the only way to do it is type examination + production quality assurance?

Or can company B apply according to annex IX even though it doesn't have a QMS for design and production?
 

chris1price

Trusted Information Resource
Hi, under the MDR, the manufacturer is required to hold a full copy of the Technical File at all times. This will have a severe impact on the Private Label Manufacturing (or own brand labelling) business. (see Article 10.4) Unless Company A is going to give B all their files, Company B wont be able to claim to be the manufacturer on the labelling.

I would suggest talking to your notified body ASAP about the options available as they will be the ones issuing the certification.
 

RobertvanBoxtel

Involved In Discussions
Currently, nothing can be done under the MDR, unless your device is Class I, as no there are no Notified Bodies designated.
Even for Class I, registration at a Competent Authority is not possible in all EU countries (yet).
Once possible, the company that intends to place it on the market under his name needs to comply with Article 10 requirements and follow one of the routes identified in Article 52.
As you as company can only comply when you have access to all technical data, that is the main issue. As indicated above, are they willing to share? If not --> no go.
 
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