Author: Douglas McGarvey
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Ask the Experts: Revision of MedDev 2.7/1 and Clinical Evaluation Reporting
We spoke with an expert from a major European notified body about how companies can prepare for revision 4 of MedDev 2.7/1 and upcoming changes in MDR rules. We discussed how these new regulations affect both new and existing products. Our expert says that the new MDR regulations pose serious implications for clinical evaluation reports based on literature review.
In the future, it will not be acceptable to build a clinical evaluation report (CER) based on literature instruction. This is a significant change! To put this in context, some 80% of products placed on the European market today are based on literature research. Industry experts think that that number will shrink to about 10% following the new MDR requirements.
What does this mean for new products?
For a new product, a literature review will no longer be sufficient
to establish equivalency with an existing product. Manufacturers must establish
equivalence between the medical device and its equivalent comparator. This requires
comparison of devices for clinical application, biological compatibility
features and technical parameters. In order to prove that these features are
the same for the two products, companies will need to have access to the
technical documentation of the equivalent product. It’s not sufficient to simply
bring the other product to the laboratory and test it. Manufacturers will need
to have two sets of technical documentation. Otherwise, the product equivalency
will not be accepted.
For ongoing/annual updates, clinical literature will
continue to be important. However, since there is no grandfathering of
certificates, every new product will basically get to the European market in
the first place based on MDR.
What about an existing product?
Once the MDR changes are in effect, the certification of
many existing products will no longer be valid. Even if an organization
certifies today, the certification will not be grandfathered into the new
system. Every organization will need to go through the new certification
process based on the new rules that go into effect in May 2020. It’s important
to note the limited timeframe for the new certification process, so companies
need to plan ahead.
With regard to current CERs, companies will need to revise
and update all clinical reviews. First, they will need to update all of the initial
CERs to meet Rev 4 of the guidance document, which is actually very close to
the MDR requirements.
Crucially, it will not be acceptable to just focus on safety
in order to update the report. It will be necessary to go back and prove the
clinical safety of the product in the first place and then to provide updates.
This is a major issue for both small and large companies.
Many companies will need to perform clinical studies and, in many cases, retrospective clinical studies. They’ll need robust programs for post-market clinical surveillance (PMCS) and post-market clinical follow-up (PMCF). With the changing rules, manufacturers will need to take a proactive, not a reactive approach, to stay compliant. Companies will need to have a very strong PMCF plan, which is different from requirements in MedDev revision 3.
What sort of
reporting is required?
companies will need to proactively collect PMCF data. Then, depending on the
product classification, they will need to produce two yearly reports with
clinical data – a Product Safety Update Report (PSUR) and a Summary of Safety
and Clinical Performance (SSCP). The data posted in those reports will come
from the company’s post-market follow-up activities.
The Commission is creating guidance documents to clarify
what it wants to see in these reports. But this reporting is not the same as a
regular CER update. The two efforts must be done in conjunction with each another.
But writing the annual reports is just the beginning – evaluation
of the reports is also necessary. Companies must upload the annual reports to
Eudamed, the European Databank on Medical Devices, and the manufacturer’s
notified body will review those reports each year.
Current discussions among notified bodies suggest that the
Eudamed databank will be available by the end of the transition period or the
month prior to the implementation in May 2020.
For further guidance, the Notified Body Operations Group (NBOG), a
membership organization of European notified bodies, may be publishing papers
with their interpretation of the regulations.
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