Regulating Medical Software and nothing new on the Recast

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 The FDA’s mobile medical apps draft guidance was discussed, and new standards were addressed, such as IEC 82304-1 regarding Healthcare Software Systems (the new product standard for standalone software)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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