REGULATORY NEWS and VIEWS II
A summary of the last year's activities (I did not want to
call it "last year highlights" because I wouldn't consider MDRs
as being a highlight).
Last year was a very eventful year for MDSS. My goal for
the year was to increase the client's satisfaction and to find out about
their needs. Next to product complaints, reports and advisory notices MDSS
handled on behalf of our clients, MDSS was inspected by the authority and
passed successfully the EN 46001 surveillance Audit.
MDSS goals in particular:
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Fulfilling 100% the requirements of the Directives on
behalf of our clients
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Informing our clients about regulatory news
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Education directed to the needs of our clients and to
enhance the expertise of MDSS
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Forwarding sales leads and business opportunities to
our clients
The business aspect is very important for any company. We
asked you to provide MDSS with the contact information of your European
Distributors. With that information, MDSS was able to forward about 300
product requests. We are delighted to forward leads and are happy that
you, our clients are successful in Europe.
Changes were introduced in the handling of technical
documentation. New European developments and pressure on the local
Competent Authority resulted in the demand that technical documentation
shall be available in Europe. In July, MDSS was officially informed of
this. MDSS developed a new system concerning the acquisition and review of
the necessary technical documentation. Accordingly, MDSS notified the
local Authority about the new system. Random inspections of the technical
files were conducted during the latter part of the year. No deviations
were found. MDSS and its clients were in full compliance of the
requirements.
At the end of 2000, MDSS was inspected on site by the
authority. A general review of our activities resulted in a few comments
on possible improvements. However, no non-compliance was noted.
With the technical documentation, we understandably
touched a very sensitive area. The main concerns were confidentiality and
the amount of paper being shipped to Europe. MDSS evaluated the feedback
of our clients to find the best solution. This was done in the following
manner.
1. Personnel meetings with clients at their business wherever possible,
meeting at trade shows and conferences and in addition, discussing their
needs.
2. Conducting Seminars throughout the year, which were geared specifically
towards our clients with free reviews and/or discussion of the technical
documentation by the experts.
3. Conducting in-house Seminars to clients on special request.
These actions were communicated as well to the Competent
Authority with very positive response.
We are happy to announce that the Competent Authorities
supported MDSS directly in its efforts as well. Dr. Ekkehard Stösslein
was guest speaker at the MDSS Seminar in January in Santa Ana, California
last January. Dr. Stösslein has been working for the German Competent
Authority for over 6 years. Since 1997 he is Deputy Head of Medical Device
Division and head of the Active Medical Devices department. His
responsibilities include the assessment of the Medical Device Reports
received by BfArM. He is member of the GHTF study group II (Vigilance) and
represents the German Competent Authority in the European Vigilance Group.
Two other Seminars were given in the US (Orlando, Florida
and Minneapolis, Minnesota).
The main work however, is taking place at MDSS to ensure
your compliance. Registration of products will be conducted only if the
documentation is available. MDSS is reviewing the files and will take the
necessary action if not sufficient. This ensures full compliance to the
requirements. 40 % of our clients have been informed to update the product
information with MDSS. We get very positive feedback in the way the
technical documentation is handled. We will finalize this task this year.
Our first newsletter was published last year informing you
about regulatory updates. A 95 % response was counted due to the request
of additional documents.
Another MDSS success for our clients is the tooth whitener
story. They are still considered medical devices, which was questioned by
the Competent Authority in Court. Dr. Hans Haindl, member of the advisory
board of MDSS was the expert witness. If this decision had been negative,
tooth whiteners would have to be removed from the European market because
the cosmetic directive as well, excludes them.
In addition to all of the above MDSS took care of its
clients in the following area.
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Inspections of technical documentation by the
Competent Authority.
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Several recalls were conducted in Europe with
notifying overall 10 Competent Authorities via the advisory notices
(the worst case for a manufacture).
-
Filing incident reports with different competent
Authorities.
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Reviewing a counted number of complaints/reports where
the decision was reached with the manufacturer not to report the
incident because they were not reportable according to the European
requirements.
None of these events led to any restrictions of selling
products to the European Union. All cases were handled in a professional
manner in working together with the client and the Competent Authority.
We at MDSSI thank you for all your support in the past and
look forward to serving you in the future as your Expert in Europe.
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