MEDDEV 2.7/1 rev.4 published - June 2016

Marcelo

Inactive Registered Visitor
#11
Mind you, it's not very likely that there will be a serious problem with a device that will only manifest in a random unit at an obscure market and not surface at all in at least one of that device's major markets.
I know and this helps the problem in general, but requirements for reporting and trending may not be related only about the problem in general, but specific occurrences, so you would still need to be aware of those.

On a more general comment, I think that, right now, these expectations may not be that clear for a lot of people (regulators and evaluators included, that's why we've been seeing a number of NCs related to these being raised recently), but newer and future regulations will make these expectations more clear, including clear requirements.

In fact, I've been having some trouble with clients because they do seem to understand PMS as only adverse event reporting and field safety actions (which is the part of PMS that is explicit regulated right now), but regulatory expectations obviously far exceed those.

One interesting problem I noted is the lack of focus on gathering (using reactive and proactive methods) positive input related to device experience which can help in several ways, for example, in confirming performance claims, being part of PMCF, confirming risk analysis, and the like. I've got some clients which are so focused on the "regulatory" PMS that they do not even have a place in their QMS to record positive feedback (and they end up being include as complaints :p).

Even with the revised MDD regulations in Europe mentioning "device experience"which includes positive and negative, my experience is that most manufacturer and a lot of evaluators have still been focusing only on negatives. And then the manufacturer has a lot of trouble to show compliance with some of the expectancies related to positives (clinical evaluation is clearly one of those).
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
Yes, I've seen it too. I think that it stems from regulatory auditors with an attitude like "Yes, that's wonderful, but the fact that your device worked for someone dosn't prove anything, especially not that it's safe". Manufacturers have been "educated" by regulators to ignore or dismiss positive feedback, for years, so it's likely to take years to reverse that.

:(
 
R

RA Princess

#13
Hi Everyone,
I wonder if anyone has had a clinical evaluation report reviewed by the NB that has followed the new MEDDEV and has any experiences to share. I have a couple of colleagues and clients that are panicking about this especially the requirement for a single equivalent device. They are worried about having to conduct clinical studies. One areas of discussion is the single equivalent device. Are they insisting on this or can you include reference to more if appropriate? I guess I'm thinking along the lines of the FDA 510k primary predicate and reference devices.
Thanks
Leeanne
 

Remus

Involved In Discussions
#14
European Commission told all NB to start using Meddev 2.7.1. rev4 immediately at October. NB's decided to ask rev4 for new applications for old applications and certified products NB should give time manufacturers until December 2018.

According to new equivalency rules, most of the manufacturers have to perform clinical evaluations. For instance Polymer monomers sold with MW range, and EC don't accept different MW range groups as chemical equivalent.

In my opinion you can use more than 1 equivalent devices. But you have to find clinical investigation from literature for each of the indication and contraindication (each of the claim).

Anyway, each notified body have different methods, its best to ask your notified body about your situation.
 

Wolf.K

Quite Involved in Discussions
#15
"Where there's no central, publicly open database and your distributors don't cooperate, I don't think it'll be held against you provided you have evidence that you seriously tried (eg contacted various distributors etc.)."

I disagree somewhat. We have contracts with all our distributors which require them to inform us about all adverse events. And we are also happy about all other information/feedback. Distributors which do not inform us - well, they are not our distributors for much longer.
 

Chrisx

Involved In Discussions
#16
One poster asked if anyone has had a CER reviewed against rev. 4. I have had one reviewed by BSI. In general, they said I had met the requirements, but issued a major nonconformity for 2 reasons.

1) I had not identified the CE mark status of equivalent devices. This is difficult to comply with, because there is not yet any publicly available database to look up CE status. I believe this is coming with the MDR.
2) They were not happy with the level of detail in the assessment of each piece of clinical literature. I blame this on my lack of a detailed assessment plan as required by rev. 4. This left the door open for them to question the degree of assessment.

I'm surprised at the comments regarding contacting distributors as constituting PMCF. Perhaps these are low risk devices. We market spinal implants and the notified body expects detailed PMCF plans with defined enrollment size defined for each indication, outcome measurements (e.g. VAS scores, fusion rates), and follow-up intervals. They would definitely not be satisfied with a few phone calls to distributors. In fact, the cost of PMCF studies may exceed the EU revenue for the product.
 
J

Julie O

#17
They are worried about having to conduct clinical studies.
I have not yet had to read Rev 4, or am I looking forward to doing so, but this statement has piqued my curiosity.

Are they worried because the MEDDEV provides clear guidance on when a clinical study must be conducted, and it seems to fit? Or because no such guidance is provided, or because what guidance is provided is unclear?
 

Remus

Involved In Discussions
#18
if you have equvalent device with clinical investigation data, you don't have to perform clinical investigation. Otherwise you have to.
 
J

Julie O

#19
if you have equvalent device with clinical investigation data, you don't have to perform clinical investigation. Otherwise you have to.
Thanks, Remus, but my question isn't really about what you do or don't have to do; it's about what the guidance SAYS about what you do or don't have to do. I ask because, if the guidance is clear on all of this, then there is nothing to worry about. Either you know you don't have to do an investigation or you know that you have to do one.

Can you point me to the section of the guidance that makes this clear?
 
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Remus

Involved In Discussions
#20
Its written even on the definitions

Clinical data: the safety and/or performance information that is generated from the clinical use of
a device. Clinical data are sourced from:
- clinical investigation(s) of the device concerned; or
- clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
- published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

Clinical evaluation: a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance
when using the device according to the manufacturer’s Instructions for Use.
Note: In exceptional cases where an instruction for use is not required, the collection, analysis and assessment are conducted taking into account generally recognised modalities of use.

Clinical evidence: the clinical data and the clinical evaluation report pertaining to a medical evice. [GHTF SG5/N2R8:2007]
 
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