|
|
 |
Title of Page
 |
 |
Updates JUNE 2000
-
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!).
-
The "Guidelines for the Classification of Medical Devices"
was updated in December 1999. MEDDEV 2.4/1-rev.6|
-
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.
-
Sweden clarifies the long lasting issue about the languages used in
their country. Swedish must be used for labelling and the instruction
for use. This applies regardless whether the user is a patient or
health professional or whether the device is used in the hospital or
in a home setting. An exemption may be granted on specific devices
which would be used if "no other options to cope with a specific
medical situation in a satisfactory manner" would be available.
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 specialized 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.
The next level of quality system standard shall be
introduced; however, 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. 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.
Return to Previous
Page
|
|
 |
