Biggest issues when producing MDR compliant Technical Files / DD

#1
Hi all,

I am working with a few friends to try to understand the EU medical device approval process better. We are working on an initiative out of Germany to try to make writing technical documentation and going through conformity assessments less burdensome for smaller companies. Obviously clinical evaluations have been a huge paint point with the new MDR regulations but I wasn't sure if that was truly the largest hurdle across most companies.

I was curious what others considered to be the largest hurdles for reaching CE mark specifically in regards to producing technical documentation.
 
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Raisin picker

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#2
The biggest hurdle, in my experience, is, that many manufacturers do not read and understand the MDR and all related documents (e.g. MDCG). Small companies often don't have the money to afford an experienced expert in QM/RA. Sending the most tedious and thorough engineer to the responsible person training (1 day) does not help the company very far.

- "My documentation was fine before. I'll just search and replace MDD with MDR and everything will work out."
- "My device warrants some exeption, because I don't want to do xxx."
- Getting your head around CEP, CER, PMS plan, PMCF Plan, SSCP, PSUR, PMS report, PMCF report. There is some overlap, but everything has to be somewhere.
- Getting your documentation sorted out to begin with. "I'll just send everything I have to the NB, they can search for whatever they need".
- Writing justifications. Something does not apply, justify it (mostly, one or two sentences suffice). MDR asks for justifications in many places.
- Starting in time. MDR is published in 2017, drafts have been around some time before. You could have prepared. But many manufacturers wanted to wait it out ...

But you also nailed it, the biggest issue is clinic. I've seen manufacturers that wanted to apply for MDR with a three year old CER that did not fulfil MEDDEV 2.7/1, had no PMCF data at all, only scanned (no OCR), 20 pages. Or just the CER from the former OEM manufacturer, still with their name on it. I've even seen a CER that claimed to be according to MEDDEV 2.7/1 (rev1 [!]), signed in 2021!
"There's no own clinical data, because I refused to do some (cheap and easy) PMCF. There's no literature data. That my device is on the market for ages is sufficient proof of GSPR fulfillment. Just give me my certificate."
 
#4
Raisin - Couldn't agree more. I feel for those engineers at smaller companies who essentially have to sort through the entirety of the MDR with little to no experience reading through regulations. The MDCG have been an immense help as each one has been released though.

It is mind boggling to me that someone would simply change MDD to MDR and changing ERs to GSPRs and assume everything is good. I am still a bit concerned about creating new PSUR's and editing our existing PMCF and PMS documentation but I think it'll take just one time through creating the documents to become more comfortable. From what I heard, most initial conformity assessments won't typically require a PSUR off the bat anyways.

I am our companies lead for clinical evaluation documentation so I'm a bit biased in what I am most concerned with so take it with a grain of salt haha.

Philip B - Thank you for this guide, this is very helpful. Do you personally use any other resources when you're writing or doing quality control on your documentation?
 

Philip B

Quite Involved in Discussions
#5
Raisin - Couldn't agree more. I feel for those engineers at smaller companies who essentially have to sort through the entirety of the MDR with little to no experience reading through regulations. The MDCG have been an immense help as each one has been released though.

It is mind boggling to me that someone would simply change MDD to MDR and changing ERs to GSPRs and assume everything is good. I am still a bit concerned about creating new PSUR's and editing our existing PMCF and PMS documentation but I think it'll take just one time through creating the documents to become more comfortable. From what I heard, most initial conformity assessments won't typically require a PSUR off the bat anyways.

I am our companies lead for clinical evaluation documentation so I'm a bit biased in what I am most concerned with so take it with a grain of salt haha.

Philip B - Thank you for this guide, this is very helpful. Do you personally use any other resources when you're writing or doing quality control on your documentation?
in addition to the BSi document I also referred to the MDR itself, 13485 and previous versions of technical files.
 
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