Medical device CER (clinical evaluation report) according to MDR

#1
hello,
I'm looking for clinical evaluation report (CER) template according to the new medical device regulation (MDR) not Meddev 2.7 rev 4.
I'm also looking for templates for clinical evaluation plan , PMCF (post marketing clinical follow up)

could anyone help me?

thank you
sebastien
 

Rincewind

Involved In Discussions
#3
Looking at the MEDDEV and the MDR it seems, at least to me, they correspond very well and from my experience usually the notified body requests the CER structured according the MEDDEV 2.7/1 rev. 4.
So what exactly do you think is not covered by the MEDDEV?
 

Sullen-gent

Starting to get Involved
#4
hello,

On this point I had assumed the same, that MDR and MEDDEV rev. 4 are aligned, and I have even been to meetings where that was said by the subject matter experts. However, I just reached out to Bsi to try and arrange some CER MEDDEV rev. 4 training (as I'm new to my current role). They have suspended this training as they say they need to make it MDR compliant and won't release it until Q3 of 2019. This was a salesperson I was speaking to so there is certainty room for confusion but taken at face value it looks the MDR does impact on MEDDEV rev. 4 interpretation in some way.

On this note is anyone aware of UK based CER training courses that are any good?
 

Thulasidharan

Starting to get Involved
#5
Hello All,
MEDDEV 2.7.1, Rev: 4 is based upon MDD only.
"A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC"
According to MDR related to CER still now only requirements available. No guidance will be updated by MEDDEV.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
hello,

On this point I had assumed the same, that MDR and MEDDEV rev. 4 are aligned, and I have even been to meetings where that was said by the subject matter experts. However, I just reached out to Bsi to try and arrange some CER MEDDEV rev. 4 training (as I'm new to my current role). They have suspended this training as they say they need to make it MDR compliant and won't release it until Q3 of 2019. This was a salesperson I was speaking to so there is certainty room for confusion but taken at face value it looks the MDR does impact on MEDDEV rev. 4 interpretation in some way.

On this note is anyone aware of UK based CER training courses that are any good?
As far as I heard rev. 4 is under review/update and rev. 5 will issue at some point and be aligned with the MDR.

Here is something else also under construction: Proposed update to Clinical Evaluation documents
 

Sullen-gent

Starting to get Involved
#9
As far as I heard rev. 4 is under review/update and rev. 5 will issue at some point and be aligned with the MDR.
Hello, thanks for that link will try to have a go reading it. I went on a MDTi course on MDR and CER and there are some points raised in the regulation that are not completely covered by the MEDDEV e.g. clinical benefit.

But one of the course attendees was a member of the EU commission working groups and told us all that the MEDDEV update has effectively been 'parked' and that it wouldn't be available for some time.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#10
Clinical benefits are covered by the current MEDDEV, but are defined under clinical performance.

Clinical performance: behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s). [EN ISO 14155:2011]
The "response of the subject" is the clinical benefit.

Why the MDR did was just separe the topics in different definitions, and put a lot more emphasis on benefits.
 

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