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Today I attended the COCIR workshop Regulating Medical Software in Brussels,
a very interesting event that brought a lot of new information to
my attention and I had the opportunity to speak to many people
close to developments in EU legislation, EU guidance and
standards.
First there was the very interesting keynote address by Ms
Sabine Lecrenier, head of unit Cosmetics and Medical Devices at the
European Commission with an update on the Recast of the Medical Devices Directives and on other
initiatives. She confirmed that a MEDDEV document on standalone
software is in the works, which is more or less ready and the
member states are expected to sign off on it in December this year,
so it can be published immediately then. The main issues to tackle
via the Recast as she mentioned were:
High level of patient protection
Adjust scope of the rules to include non active tissue products
and cosmetic implants, as well as genetic tests
Strengthen control on notified bodies
Ensure timely and uniform action in vigilance and PMS must be
ensured.
Improve clinical evidence requirements
Improve borderline products rules
Management of regulatory system will be looked at with a view
to int trade, in which the Global Harmonisation Task Force (GTHF)
will play an important role.
This is nothing new compared to what we knew from the earlier Council Conclusions, which I suppose is good news for
the industry although many specifics remain unclear, like the way
notified bodies will be controlled - in that respect there are two
remaining options now I understand, one of which is oversight by
the
EMA. Adoption of the final Recast text is still foresoon in the
first half of 2012.
During the day it became clear that there is still a lot of
controversy about the scope of the rules on medical devices with
respect to software. The FDA's mobile medical apps draft guidance was
discussed, and new standards were addressed, such as IEC 82304-1
regarding Healthcare Software Systems (the new product standard for
standalone software) currently under development. Other interesting
discussions concerned the difference in regulation of software that
stores data between the US and the EU, in which field the US seem
to be stricter than the EU and look more at the risk of the
integrity of information, while in the EU the only question is
whether the intended use of the software is directly therapeutic or
diagnostic. There is furthermore a difference between the two
systems in that the FDA has the grey area in which it exercises
enforcement discretion, while the EU authorities have to use a
binary criterion (device or not) and operate on that basis.
All in all a productive day. If you were not there, I understand
that the presentations can be downloaded from the
COCIR site. If you are interested in regulation of software
under the medical devices directives in the EU, you should.
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