26 • ODT odtmag.com January/February 2014
How to Handle Medical Device Vigilance Cases
with European Competent Authorities
Ronald Boumans • Emergo Group
The European Commission’s MED- DEV 2.12/1, which is a guidance document that covers the Medical
Devices Vigilance System, describes how
a manufacturer should communicate with
competent authorities about vigilance
cases—which are triggered when there
is an incident with a device. A competent
authority is a body with authority to act on
behalf of the member state government
to ensure that member state government
transposes requirements of medical device
directives into national law and applies
them. This particular MEDDEV provides a
Manufacturer Incident Report. While this
document may look as if there is not much
freedom in how to report, there is. And
manufacturers should try to make good
use of this. As an inspector of medical
technology at the Dutch Healthcare Inspectorate, I saw many reports. It probably
doesn’t come as a surprise, but there were
big differences in reports—even when the
Manufacturer Incident Report was used—
and those differences could affect how
cases were handled.
This column will share five secrets
about how competent authorities typically
handle vigilance cases, and how you can
improve the way your cases are handled.
Remember, however, that this is not
a guide for how to mislead a competent
authority. On the contrary, this is a guide
on how to make sure you are clearly
understood when you report an incident.
Competent authority staff behave just like
normal people. Brace yourself. This may
come as a surprise: Competent authorities are manned by normal people. Their
behavior will not differ significantly from
your own. And what’s more, the working population at the competent authority probably will be quite similar to yours.
That means you will have to take into account that your report will be read by an
“average” staff member who often is junior level. Even worse, if your report ends
up in the hands of senior staff, or even the
head of the organization, that will usually
mean bad news. That junior staff member
most likely will not fully appreciate the
subtle wordings of a senior legal consultant. And if your report is not fully understood, it may not be handled correctly.
They have no idea about your device. Another surprise to you may be that most
competent authorities have no idea what
your device is about. That is not due to
lack of expertise or interest, but to the fact
that there are thousands of different devices out there, and most competent authorities simply don’t have the manpower
to go into details about all of the devices
that are distributed under their responsibility. They only will do that when needed.
Under normal circumstances, it is not always a good thing if a competent authority spends time looking into your device.
That means when you write your report,
you should make sure you are clear about
It won’t hurt if you describe the
intended use of your device clearly in your
incident report by answering the follow-
• What does your device do?
• How does it work?
• What is the patient population?
• Who is the intended user?
• What are the criteria for use?
• What are the criteria for exclusion?
• What are the start and stop criteria?
• What are the specific risks?
In some reports, the box for Class lla
was ticked, so my first guess was that
these were invasive devices targeting nat-
ural orifices. But into which orifice should
the devices be inserted? Sometimes the
answer to such a question means the dif-
ference between a low risk, standard case
and a case that would demand immedi-
ate attention. So, be clear about the nature
of your device, even if it seems to be ex-
tremely evident to you. You will help the
competent authority staff member who
does the first selection immensely.
Not all cases get the same priority. Typically, manufacturers are expected to deal
with vigilance cases. The compulsory reporting according to the MEDDEV only
is done to give competent authorities an
opportunity to see if manufacturers take
this responsibility. If a case is considered
serious, competent authorities may want
to act independently from the manufacturer. That means incoming reports get
priority, and most of the time that will be
a low priority. Again, if your report gets
high priority, this usually means bad news.
The only thing worse would be a situation where your report is considered to be
low risk, while it should have been high
risk. The competent authority may get the
idea you didn’t inform well. I can strongly
recommend avoiding such a situation. It
is important for manufacturers to understand the importance that the competent
authority gives the right priority to your
report as soon as possible.
On every desk there are three piles. Competent authority staff handling vigilance
cases typically will use a system with three
piles of work on their desk. On one side
there is a small stack of cases. These are
the complex, high-risk cases, often handled by senior staff.