Regulatory News and Views I
By: Ludger Möller
MDSS is implementing a
newsletter containing information on regulatory
affairs and other areas of interest for our clients.
Our goal is to provide you with a synopsis and
clarification of the European regulations, thus
providing you with the basic tools to make the right
decision in regards to your company’s regulatory
matters.
Updates
The European Norm EN 980
“Graphical symbols for use in the labelling of
medical devices” from May 1996 was updated with
Amendment 1 in August of 1999. Not many changes were
introduced. Only clause 4.6 Symbol for “STERILE” and
4.7 Symbols for “STERILE”, including the “Method of
Sterilization” were changed.
There is no need for
concern; the symbol remains the same. The clause was
updated by adding that the symbol is only applicable
if the product is sterilised in its final package.
Also, the reference to EN 556 was revised to be more
precise. Please refer to the official document for
the exact wording (Copyright!).
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The “Guidelines for
the Classification of Medical Devices” was
updated in December 1999. MEDDEV 2.4/1-rev.6
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The guidelines “On a
Medical Device Vigilance System” are in the
process of being updated. A “draft working
document” was released. MEDDEV
2.12/1-rev.4 from June 6, 2000.
A summary and
interpretation of changes in the guidelines will be
provided in the near future. If there are any
questions, please do not hesitate to contact us. If
you wish to have a hard copy available for your
reference, please fill out the return form and fax
it back to us.
This refines one of the
last unclear language requirements in the European
Union. Sweden was very often used as an example of
the countries, which might accept other languages.
It is a business decision for manufacturer to decide
whether it is worth to invest on translation in what
may sometimes be a very small market (please do not
underestimate the marketing advantage in providing
information in the national language).
The exemption, Sweden allows in the regulation, is
based in my opinion on common sense. A manufacturer
with specialised devices who supplies a small
specific medical market might not be able to provide
translations. Sweden has provision to allow the
market and use of these devices.
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There is no news on
the DIS ISO 9001: 2000 standard. A vote in March
by the standard committee was 80% in favour of
the document. Even with the high ballot, the
draft is still controversy in all areas. The
standard committee is working to implement
changes. A new vote is currently taking place.
The final version of the standard is to be
expected in November.
The next level of
quality system standard is planned on being
introduced. Since this document is still under
discussion, especially amongst professionals in the
medical area, it will be interesting to see how the
regulatory bodies in the US and Europe will handle
the changes. In the US, the situation is clear.
Nothing will change until the FDA changes their
rules. Before the standard can be used to show
compliance to the Medical Device Directive, the
European Union has to release the so called
harmonized version of the ISO standard (EN ISO
9001). Prior to this being accomplished, the
particular standard ISO 13485 (EN 46001) will have
to be updated in order to make the ISO 9001 standard
applicable for medical device manufacturers. The
European Union could move faster since changes will
not be necessary to the Medical Device Directive.
Any comments or question
on the above news and views can be directed to
info@mdss.com
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