DHF, DMR and DHR in MDR?

[Paul_1993]

Hello,

I have got a question regarding the improved technical documentation in the MDR. As I understand it, the medical device file (ISO:13485:2016 4.2.3) is similar to the DMR in the USA, so that the medical device regulation in Europe and the USA approach each other.
Do the MDR in Europe also implements something like a DHF or DHR in Europe? Or is a documentation about the design history in Europe not necessary?

Thank you all in advice,

greetings from Berlin!
Paul

 

[shimonv]

Hi Paul,
Below is a quote from BSI Medical Devices – ISO 13485 FAQs:
"Clause 4.2.3 – Medical Device File
What type of file does “Medical Device File” refer to?
“Medical Device File” refers to both the device master record, and the technical documentation (technical file or design dossier). The requirements of this clause were previously documented in Clause 4.2.1 in ISO 13485:2003 and EN ISO 13485:2012."

So then, the Medical Device File is more than DMR. It's DMR plus all required regulatory submission files (i.e. 510(k)/PMA).

As for your second question, the DHF is similar to "Design and Development" section of the ISO 13485 standard, which is recognised as means to demonstrate compliance with the European regulation. And yes, you do need to have DHF/Design and Development procedure and records.

Shimon

 

[biokeithmed]

For technical file(s) from MDD to now MDR, what is the format of the document that needs to be filed out?

 

[shimonv]

Refer to MDR Annex II and III.
The following image is taken from BSI guiding document on this subject.

 

[Paul_1993]

So if I got the point right:

If I want to approve my medical device in Europe with the MDR standards and ISO13485:2016, I already have a DHF and DMR, that are complete enough for the U.S. standards?
I thought, that European manufacturers have got trouble to approve their medical devices because the requirements for the approval process in the U.S. are higher because the DHF is way more comprehensive than in Europe.

Thanks in advice,
Paul

 

[shimonv]

Hi Paul,
Although the QMS baseline is similar, the European regulatory layer (burden) is significantly different than that of FDA.
Just for example, in Europe you need to include a Clinical Evaluation Report as part of your technical file; another example is post-market surveillance requirements. You will need to deal with a notified body and update your QMS with some additional procedures (e.g. translation procedure). And so on...

 

[rob73]

This is how we are dealing with it (copy of file index attached)
It includes all information from concept to manufacture and PMS activities.
Gonna be a big one!!