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By: Ludger Möller
News and Views
July 2006
Content:
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11 Year Anniversary
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Regulatory Updates Directive Update
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Classification Update
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New MDSS Address
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MDSS, the only Authorized Representative
certified to EN ISO 13485: 2003
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Logistics and Distribution in Europe
Dear valued Client,
July 2006
11 Year Anniversary
You may ask why celebrate the eleventh year and not the tenth
year anniversary. This is actually a good question. We simply
did not find the time to do so. Therefore, we thought 11 years
is also a good number. We want to celebrate with you, our
clients, who helped us to be the successful business we are
today. Our special for our clients are free seminars. The main
topics are going to be the updates of the MDD and the Vigilance
guideline. That the MDD is being updated is known in the
industry but the vigilance guideline is also in its final stages
of endorsement and will bring some significant changes to the
European vigilance process which should be taken into
consideration in your quality system. Other topics are Labeling
Compliance, Product Notification Process and Competent Authority
Interventions. Please go to our website to find more details
www.mdss.com
Regulatory Updates
Directive Update
There is no news regarding the Medical Devices Directive since
our last newsletter. The review is ongoing. The next step for
the commission is to bring the text to the European parliament.
In there the revision has to go through the legal proceedings
with readings and voting. A very optimistic timeline for its
release is early 2007 but it may take significantly longer.
Further details will be given during the seminar series and
in future newsletters.
Vigilance Guideline Update
A subgroup of the Medical Device Expert Group (MDEG) worked for
quite some time on the update of the Vigilance Guideline MEDDEV
2.12-1 rev. 4 from April 2001. This guideline will have to be
endorsed by the MDEG itself to be accepted EU-wide. The subgroup
consisted of members of the industry associations and various
competent authorities (CA). One goal was to keep the European
document in line with the Global Harmonization Task Force (GHTF)
document. This was not possible in all areas due to CA
intervention. As soon as the new guideline is released it should
be used when complying with the European post marketing
activities. There are significant improvements to the document
which should be taken into consideration in your quality system.
The areas of improvements are:
* Definition section has been implemented;
* Notification of recall has been clarified;
* Incident, near incident and timeline clarification;
* Information exchange has been improved;
* The concept of use error was introduced.
Further details will be provided during the seminar series
and in future newsletters. MDSS will be happy to review your
vigilance procedures to ensure the compliance.
Standard Update
The standard EN ISO 13485:2003 replaces EN ISO 13485:2000 on
July 31, 2006. This deadline is the end of the transition
period. All companies that utilize the EN ISO 13485 for
compliance for CE marking are in the need to update the
certification. Any future audit should be conducted to the EN
ISO 13485:2003 standard. We would assume that your notified body
already informed you since it is a major part of their business.
Classification Update
Total Joint Replacements have been reclassified to risk class
III. The reclassification was achieved via the European
Directive 2005/50/EC which was published on the August 11, 2005.
Article 3 of the directive clearly outlines what needs to be
done and when. Manufacturers have time to update their files
until 2009 respectively 2010. Please refer to the original
document.
New MDSS Address
MDSS is proud to announce that it will move to a new permanent
address. The building we are going to occupy will now belong to
MDSS. The address is the most important aspect of the AR. We are
fully aware of this and therefore we made provisions to keep the
old address valid until at least 2012 and even longer if a
client will have difficulties to change his labeling.
Nevertheless, we would like to ask you to update with the next
label and instructions for use revision the MDSS address. This
is as well a good opportunity to utilize the AR symbol from EN
980. Please see below the example on how to disclose the AR.
MDSS, the only Authorized Representative certified to EN ISO
13485: 2003
MDSS was the first AR to be certified to EN ISO 9002: 1996 and
EN 46002. We updated our system to the new EN ISO 9001: 2000 and
the EN 13485: 2000. Now we are certified to the new EN ISO
13485: 2003. According to our knowledge we are the only AR
achieving this certification in the interest of our clients. The
certificate was issued by TUV Product Service the market leader.
Enclosed is a copy of the certificate for your vendor file.
A quality system certificate from a reputable notified body with
the applicable quality system standard should as well be
acceptable to your notified body as vendor approval.
Logistics and Distribution in Europe
MDSS as your AR in all matters of European regulatory affairs
has been approached by clients to offer solutions for
distribution. This is a different business and MDSS should not
be involved in the distribution for very valid reasons. For
example would other distributors of yours accept the prominent
position of MDSS on your label and be in competition? It is very
difficult for a distributor to make the right independent
vigilance decisions! This could compromise your responsibility
for vigilance
Next to our office in Atlanta a logistics and distribution
company is setting up their US subsidiary for the support of US
companies for the logistics and distribution of products in
Europe. We would like to recommend their service and also give
them an opportunity to present themselves here.
Realize your success
From Prestige Promotion GmbH
Selling products within the European Union can be difficult at best. Although EU countries are making attempts to become more
standardized, Europe consists of 25 different countries, nearly
each with their own language, customs and additional local
regulations next to the CE mark. Therefore, a secondary
packaging process for health care, medical devices,
pharmaceutical or cosmetic products is often necessary in order
to meet all applicable laws and guidelines or simply to
distinguish markets.
Helping medical devices, pharmaceutical and cosmetic
companies to overcome these obstacles has been Prestige
Promotion’s main goal for over 12 years. Prestige Promotion is
certified to pack and distribute medical devices,
pharmaceuticals throughout Europe, according to the Good
Manufacturing Practice (GMP) standards, the German
Pharmaceutical Act (§ 13 AMG) and soon EN ISO 13485:2003. This
guarantees that your products will exceed each and every
standard necessary for success in the European market.
Prestige Promotion provides a full range of customized
logistic services, from secondary packaging to storage, order
compilation and distribution. The company’s main strength is
flexibility – it offers unique solutions based on the individual
needs and requirements of their clients. With more than 200
employees and a 5,600 m² facility ground located in the heart of
Europe, Prestige Promotion is capable to meet all packaging and
storage needs.
With an outsourcing partner like Prestige Promotion you can
keep your focus on your core business, while being assured that
your products are in good hands.
Realize your success within the European market.
For further information see www.prestige-promotion.net
or call Margit Stüber +49 6027-46 14 24.
German Office
Prestige Promotion GmbH
Lindigstr. 6
D-63801 Kleinostheim
Tel. +49 6027 461 424
Fax +49 6027 461 450
US Office
Prestige Promotion
530 Means St.
Suite 120
Atlanta, GA 30318
Tel. 404 586-6839
Fax. 404-586-6820
Certainly if you have any questions or would like to have
further clarification, to any of the above do not hesitate to
contact us.
Yours sincerely
Ludger Möller
President
MDSS
Abbreviations Used
MDD - Medical Device Directive
IVD - In Vitro Medical Device Directive
EN - European Norm (harmonized standard if published in the
official Journal of the EU)
EU - European Union
ISO - International Standard Organization
AR - Authorized Representative
MDEG - Medical Devices Expert Group
GHTF - Global Harmonization Task Force
MDSS - Medical Device Safety Service GmbH
CA - Competent Authorities
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