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EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean?

S

ShRam

Starting to get Involved
#1
#1
Hi,

In EU MDR, Annex XIV-Clinical Evaluation Plan says, "a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects"

What do these methods mean?

TIA!
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
shimonv

shimonv

Trusted Information Resource
#2
#2
methods is the procedure.... plan, sample size, inclusion, exclusion, protocol, instrumentation, monitoring, etc.
 
B

Biomedical_engeener

Starting to get Involved
#3
#3
Is clinical evaluation needed if device is already place on the market under MDD ?
What is the dofference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we was self-certificated before.
 
S

ShRam

Starting to get Involved
#5
#5
Biomedical_engeener said:
Is clinical evaluation needed if device is already place on the market under MDD ?
What is the dofference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we was self-certificated before.
Click to expand...

Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation. Clinical investigations that are done after your product is placed in the market is Post Market Clinical Follow up (PMCF).
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#6
#6
ShRam said:
Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation.
Click to expand...
Should be: Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation investigation.
 
P

Philip B

Involved In Discussions
#10
#10
Recommend you read the MEDDEV guidance on clinical evaluation (2.7/1 rev 4), we based ours on this. It's a lengthy and detailed document so you need to put aside considerable time for this. If you meet the MEDDEV there is a presumption you meet the regulation.
 
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