EU MDR - Contract Manufacturer vs Legal Manufacturer

[DRWoodcox]

My company operates as a contract manufacturer in the UK for several different medical device manufacturer. For one manufacturers, we have, as a service CE Marked the finished devices we produce for them and maintained the technical files. We do not market the devices under our name or trademark. I have the following question regarding the EU MDR:

As a contract manufacturer, CE Marking devices for a Manufacturer, do we need to maintain the technical documentation?

The reason for the question is that since we don't market the devices, the EU MDR doesn't appear to include us in the definition of Manufacturer and I can't find any reference to a contract manufacturer or anything else in the EU MDR that would apply to my company.

 

[chris1price]

Hi,

Ultimately, it comes down to who's name is on the packaging as the manufacturer. Whoever it is, must hold the Technical files. If it is your name, then you issue the DoC and are responsible for ensuring all the requirements of the MDR have been met.

 

[dgrainger]

There is a mention in Article 93.3(b) that implies that competent authorities might visit you to check conformity including "a review of documentation":

"the competent authorities...shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users."​

 

[DRWoodcox]

As I’ve been digging into this question further and reviewing the responses so far, I find I have a follow up question that shows how little I understand regulatory affairs: Can we continue to apply our CE Mark to a device if we do not maintain the complete technical file on the device?

 

[chris1price]

As with many things, the answer is "it depends". Assuming you are still working under the old MDD and it is a relatively low risk product, I would firstly say it is not your CE Mark, it is the products CE Mark. The required technical information could be held anywhere as long as it is readily available, complete and kept up to date. There would also need to be a agreement or contract tying all these and the companies together. Then one entity has their name on the product, ensures all the conformity assessments are complete, and generates the Declaration of Conformity in their name.

This is a very simplistic outline, but in under the MDD it was possible.

To answer your specific question; yes you can, but you need to ensure, through audit and agreement that the technical file is complete, and that all the necessary requirements of CE Marking (Clinical evaluation, quality systems, complaints, PMS, etc) are in place and available for a NB to inspect.

Under the MDR, all bets are off. The MDR has been written in much tighter language throughout, and there are many more requirements to follow. The Notified Bodies will also be working much more rigorously then before and enforcing the rules. Tying all the components together will become more difficult.

Drop me an email if you want to talk about it some more.

Chris