OCTOBER 2009
Addendum to:
“Hello,
Europe. Be the first to meet my new product.”
Our last Pulse article about
when and how to introduce your pharmaceutical or medical device in Europe
generated a lot of interest. Clearly, many of you have been thinking — or
this article got you started thinking — about a European product launch.
In the article, we touched on
the European Union's (EU) requirement that medical devices be issued a CE Mark
before they can be marketed. Because we received requests for more
information on this, we decided to do an addendum to the article to answer a
few of your questions.
The
CE Mark certifies that the product meets EU standards for health, safety,
quality and the environment. Once a medical device has received CE Marking, it
can be marketed in all the EU countries (currently 27) without undergoing
additional scrutiny or requirements from individual countries.
The
first step is to determine your product's risk class: Class I are considered
low risk (e.g. wheelchairs), Class IIa are low-medium risk (hearing aids),
Class IIb are medium risk (ventilators) and Class III are high risk (prosthetic
heart valves, for example).
You
can determine your product's risk class by consulting the Medical Devices
Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD) or
the In Vitro Diagnostic Medical Devices Directive (IVDD).
The
requirements and standards for each class are outlined in the directives. ISO
certification is not mandatory to meet CE Marking requirements, but compliance
with ISO 13485, which outlines a comprehensive management system for the design
and manufacture of medical devices, is certainly a plus.
Low
risk devices can be "self certified," meaning that once you have
determined that your device is low risk and you have met the requirements of
the relevant directive, you can place the CE Mark on your device. Higher risk
devices require that a "Notified Body" audit your quality system to
certify that you have complied with all requirements as laid
out in the applicable directive. A Notified Body is an organization recognized
by the European Commission to approve medical devices covered in the
directives.
A
well-designed European Opportunity Assessment will help you understand how your
device should be classified, whether a Notified Body audit is required, and how
to certify your medical device and implement and manage your quality system in
a way that maximizes your market opportunity.
Special thanks to Glenn
Neuman of New World Regulatory Solutions (www.newworldreg.com) for his valuable input in this
expanded explanation of EU regulatory requirements.
If you missed the original
article, or want to know more about European Opportunity Assessments, read
"Hello, Europe. Be the first to meet my new product." You can find it here
on our website.
To our Subscribers: If you want to generate more sales by launching your product
on the other side of the Atlantic, please contact Robert Keefer or Reinhard
Merz for a free consultation and to see if we might be of assistance. In
today's fast-pitched world and pinched economy, every new market can bring tangible value to you. We can help you think
through your options, and we would enjoy working with you. Our phone
number in NC is 919-354-4204, and in Germany it is +49 6221-27262.
To contact the publisher and editor of Pulse©, or to learn more about how
TCG can help you, please contact rkeefer@tcgbiopharma.com.
UPCOMING
EVENTS:
AdvaMed 2009
October
12-14, 2009, Washington, DC
Updates on the impact of US healthcare reform on
medical products and pricing, plus
1000 attendees for one-on-one partnering discussions and new tech
presentations.
Read
more and register...
Seminars
on key developments for EU firms considering the US Market
October
and November, 2009
Three TCG seminars in Germany focus on the special needs of the
medical device industry. Our market experts give insight to the opportunities
and threads of a market entry in the US.
Read
more and register...
Pulse is
published by TCG LLC of Research Triangle Park, NC.
For more information, please call 919-941-0700 or see our website:
http://www.t-c-group.com/