Medical Products: CE Marking - Are the DMR's, Technical Files, DHF, required?

[vinqua]

Are the DMR's, Technical Files, DHF, required before or after "a new medical product is out into the market after CE marking is applied for"?

[GStough]

Originally Posted by vinqua

Are the DMR's, Technical Files, DHF, required before or after "a new medical product is out into the market after CE marking is applied for"?

Hi Vinqua,

I'm no expert, but it would make sense to have these documents in order before applying for CE marking. The Device Master Record (DMR) and Design History File (DHF) are required to manufacture your product, per FDA's QSR. Technical Files would need to be assembled prior to submission for CE marking approval, I would think.

Again, I'm not an expert in the CE marking area, but this might help you get started until other more knowledgeable Covers offer their input.

[Al Rosen]

Originally Posted by vinqua

Are the DMR's, Technical Files, DHF, required before or after "a new medical product is out into the market after CE marking is applied for"?

All are required prior to application. The first step in both processes is to determine the device classification.

Depending on the class of the device, in the US you probably need to file a 510(k) with FDA then register your establishment and list the device after it is cleared. The FDA will inspect your establishment and expect to to see DMR and DHF. Look at FDA Device Advice for more details.

For CE in Europe depending on the device class you should contact a Notified Body to help guide you through that process, but you will need to have a ISO 13485 registration and a technical file that they will review before you can place the device on the market.

Sorry for the short answer, but I don't have lots of time lately.

[hazu123]

The Technical File should be completed before affixing the CE marking. By affixing the CE marking, a company indicates that the product is in compliance, and that they can prove it.
Without having a Technical File you cannot ensure compliance. Moreover, a Technical File is one of the requirements of CE marking. Without the Technical File, the CE certification would not be complete...

Han

[Tiffany]

Anyone can share the sample of Device Master Records and Device History File?

Tiffany

[Ajit Basrur]

Originally Posted by Tiffany

Anyone can share the sample of Device Master Records and Device History File?

Tiffany

For Device Master Records (DMR), refer HERE

Regarding Device History record. there is no such template as it totally relates to the device and your system. Refer Wanted: Device History Record (DHR) Templates

[MIREGMGR]

One would hope that, at least for a device that is designed and developed by the same organization that will market it, there would be an understanding in place of how to be compliant before the beginning of that design-and-development process. It would be challenging to retrospectively create a compliant medical design and manufacturing context from scratch, at least for a Class II sterile device, without a lot of prevarication.

Everything depends on classification. That determines the type of compliance that the FDA expects, and the posture they will take in regard to its verification; and the nature of the compliance record required for 13485, and the correct form of the resulting CE mark.

For the FDA, a Class I exempt non-sterile incidental-patient-contact device that's not subject to any special rules requires relatively little compliance effort beyond basic recordkeeping, correct and non-misinforming labeling/literature, and complaint responsiveness, and is likely to receive infrequent oversight. Class I sterile devices additionally require validated processes. Devices with significant patient contact require ISO 10993 contact-materials biocompatibility. A non-exempt device, including most Class IIs plus a few Class Is and some other special cases, requires a pre-market 510(k) and may be subject to substantial review and inspection. A Class III device, of course, in general requires a far more complex and closely-overseen PMA process, extesnive materials qualification and process validation, and a pre-release inspection.

For 13485, one would think that it would be hard to obtain authorization for a CE mark via a business relationship with a Registrar, even for a Class I device and certainly for a Class IIa and above, without having a substantive compliance context well in place and working.

I'm sure I've over-generalized, not knowing the specifics of this instance, but the OP's question has a lot of complicated implications.