Clinical Data Report - Literature Route - MEDDEV guidance (MEDDEV 2.7.1)

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Roland Cooke

#22
We moved away from allowing "We will just follow the Guidance" for all MEDDEVs a long time ago. People didn't understand the guidance, and even if they did, they didn't follow it.

"Forcing" them to write a procedure based on the Guidance proved to work well.
 
S

SteveK

#23
FYI

I capture the Clinical Evaluation stuff in my PMS SOP.

See thread:

EDIT ADD: The link didn't come over in the migration. Sorry.

Steve
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#24
I capture the Clinical Evaluation stuff in my PMS SOP.
Was that a document you shared here? Checking for old and otherwise broken links in posts. Unfortunate he link didn't come across. Sorry.
 
R

Roland Cooke

#25
( I'm referring to 93/42/EEC here, doubtless the new EU MDR has different / additional requirements. )

All devices require clinical evaluation in advance of placing on the market (Annex X). In rare circumstances Annex X 1.1.1.d may apply.
Note that this does include all those devices for which design control is optional.
However design control (and change control / regulatory change control) are good places to include such procedures.

Once the device is on the market, clinical evaluation must be updated at appropriate intervals. This is typically driven by PMS and PMCF feedback. That could be daily! I recommend an annual update at minimum.

For well-established devices, for which PMS data tends to be very static, I still recommend a positive statement to that effect in the technical documentation.
 

pkost

Trusted Information Resource
#26
( I'm referring to 93/42/EEC here, doubtless the new EU MDR has different / additional requirements. )

All devices require clinical evaluation in advance of placing on the market (Annex X). In rare circumstances Annex X 1.1.1.d may apply.
Note that this does include all those devices for which design control is optional.
However design control (and change control / regulatory change control) are good places to include such procedures.

Once the device is on the market, clinical evaluation must be updated at appropriate intervals. This is typically driven by PMS and PMCF feedback. That could be daily! I recommend an annual update at minimum.

For well-established devices, for which PMS data tends to be very static, I still recommend a positive statement to that effect in the technical documentation.
Hi Roland

I'm interested about yuor comment on well-established products - what sort of positive statement would you consider?

taking a hypothetical product that has been on the market since the 19th century, while I can clearly see that I have had no new trends in my complaints, how can I evidence that there is no new clinical data without conducting a search of literature and reviewing the results? In the past I have relied on evidence of my experience and expertise to make a statement to the effect that, "I'm an expert and I know there is nothing new in this area", however that doesn't seem to wash with NB's any more
 
R

Roland Cooke

#27
Well there's a couple of different things in play there.

First, by a positive PMS statement, I mean in comparison to saying nothing at all. Even for a well-established product, you can still demonstrate you have done your (annual-ish) due diligence from the regular sources of market feedback.

Secondly, a well-established device is unlikely to have a lot of recent (or perhaps even ancient) clinical papers describing its efficacy, however you may be able to demonstrate that it is so ubiquitous and well-established that its use is taught as standard in medical schools and the like. Use your experience and expertise to make that case, backed up with appropriate data.

Finally, I would recommend manufacturers of such devices consider Annex X 1.1.1.d as a start-point, can the safety and efficacy of the device be justified without a clinical evaluation being performed?
 

pkost

Trusted Information Resource
#28
Where we have longstanding products, their safety and efficacy is normally evidenced by showing that they have been on the market for many years with little to no problem (beyond normally identified risks such as breach of sterility). That in itself is clinical data and therefore makes 1.1.1d moot.

Do you think it is feasible to carry out an initial clinical evaluation where it is concludes that the product is safe and effective from decades of historic use, and then state that no further evaluation of clinical data is necessary and that only complaints/customer feedback will be considered in future?
 
R

Roland Cooke

#29
Do you think it is feasible to carry out an initial clinical evaluation where it is concludes that the product is safe and effective from decades of historic use, and then state that no further evaluation of clinical data is necessary and that only complaints/customer feedback will be considered in future?
Good question, above my paygrade I'm afraid (need to run that by a proper clinical person!). :)

My _guess_ is "no", in that evaluation of (new) clinical information is a fundamental part of post market surveillance, but it's possible you could make the argument on a case-by-case basis.
 
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