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Edwards Lifesciences' Rainer Voelksen on Harmonisation of Software Requirements through Standards

Contributor: Helen Winsor
Posted: 12/04/2012
Helen Winsor
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Rainer Voelksen, Vice-President for International Regulatory Affairs at Edwards Lifesciences, joins Pharma IQ to discuss why standards should have internationally compatible software requirements. He also touches upon the European QM approach, the GHTF project and the International Medical Device Regulator Forum in the interview.

 Pharma IQ: Today I’d like to get a regulatory update from you and we’ll break it down into a few different subject areas. First of all I’d like to ask you why standards and not mandatory decrees or ordinances as part of the laws; what’s the reason for this?

R Voelksen: I think it’s an interesting question and at least in the European regulatory framework there are always discussions coming up for the reason why standards are not formally implemented into regulations. I think the advantage is that standards can be changed easier and especially updated and brought up to the current expertise and current knowledge, especially if we talk about technical standards and especially in this context of software standards. To change any regulation would take too much effort from the regulator, from the government, from the EU Commission if it would be a European Directive or probably through a European regulation lever. So I think it’s an advantage that standards are out of the regulations and I think it’s easier to amend them to be always up to date.

Pharma IQ: I’d like to ask you about the success of the European QM approach which started with the first GHTF project in 1992 internationally. Can you talk a little bit about the success of this please?

R Voelksen: That’s an interesting question. Even it has probably less to do with software but obviously all the standards and all the regulatory requirements are nowadays embedded in the quality system requirements. If you are talking about the European system and the e-marketing for devices to be placed on the market in Europe, indeed it was Europe who pushed in 92 to create the Global Harmonisation Task Force called GHTF. And one of the first achievements I think that has been recognised globally is really to have a quality system imposed for the manufacturing of medical devices. And even if the current standards, ISO 13- 485 is not officially recognised worldwide, the quality requirements in those standards and for the e-marketing, you can find them back now in the FDA requirements in the QSR. And a lot of countries, Canada, a lot of Asian countries have taken over ISO 13-485 as a basic requirement for medical device manufactures and even recognised nowadays notified body certificates in Canada and some other countries. It’s not notified bodies, it’s called conformity assessment bodies. So I think this early initiative by the European Commission is a great success not only for the European system itself but merely has been promoted thanks to GHTF worldwide.

Pharma IQ: And what’s the benefit for the software regulations specifically?

R Voelksen: As I said, if countries copying the European system, they also ask for standards for specific product requirements and we have standards for a lot of different products, and again those are standards where FDA uses a lot of regulations and publishes it in their Code of Federal Regulations, the European system is based on the quality system approach and then we are talking about the essential requirements. And embedded in this system are all the requirements for any medical device be it a wheelchair, be it a pacemaker, be it x-ray 2

equipment or MI equipment. So depending on whether you have software, obviously you have to fulfil those requirements translated into your product, into what you are placing in the market be it standalone software in addition to any available product or be it a huge software component like in imaging diagnostics where software is nowadays the invention and part of the product to make images easily detectable for the physician and to have better images to first diagnose and to treat the patient. So the quality system imposed and the requirements for standards allow also that software standards are embedded in the whole system.

Pharma IQ: Why are there different regulations for software? Can you explain that?

R Voelksen: That’s a huge challenge we as manufacturers are facing and again regulations are still quite different from country to country, from region to region. We are working in different settings including health associations, including with the European Chamber of Commerce and different areas of the world to harmonise these standards for software requirements. One of the challenges we see currently is the implementation of the 6.01 standards because we have now the third edition available so a lot of countries are requesting that your product has been tested and fulfils certain conditions of those very standards. We have some other countries where there are a lot of national manufacturers who are still not following this development and are requesting the second edition of the standards which is outdated for a lot of regulators and therefore a lot of companies try to fulfil the third edition. So it is a challenge to harmonise national standards with ISO standards, and even if we have one ISO standard, as I said, that needs to be updated. If we want additions it makes it sometimes difficult for manufacturers to decide which version of a standard to follow. The differences in the requirements come really with the amount of national manufacturers. Sometimes it could be considered a national protection measure if a country has a lot of national manufacturers who are not yet up to speed with the latest edition and they still request the older version of a standard which is sometimes not easy to fulfil for Western European/American companies who want to be top and want to have the latest edition implemented into their product.

Pharma IQ: Is the International Medical Device Regulators Forum relevant for the topic of software and standards in your view?

R Voelksen: That’s a very good question. As you asked me earlier about the quality system approach and I mentioned GHTF, for the good and for the bad, the regulator forced the closure of GHTF after 20 years exactly. In October this year in Tokyo, it was the last conference of GHTF. But since the beginning of this year the so-called IMDRF, the International Medical Device Regulators Forum has been established as the forum among regulators officially where those regulators, the same five from the GHTF, are now officially members. China and Russia have been invited. WHO is already an observer, the EU is also with standards and one of their working groups, led currently by a member of the German Ministry of Health, tried to find out how many standards are currently officially recognised by the six, including Brazil, by the six members of IMDRF. It’s a pity to say in the last update I have seen there were only 17 standards which had been officially recognised out of 1,700 which had been found as so-called international standards, which means not only ISO but also European standards or standards which are in use in at least more than one region of the members of IMDRF. Out of 1,700 ISO and other standards, more or less 17 or 20 perhaps are recognised. But at least the IMDRF is looking into it and the idea is that they are working together to recognise more and more among each other out of these 1,700 standards which also include software standards. So I think it’s a great push and I think industry should be getting closer involved in IMDRF and this working group to make sure that as much as possible internationally used standards in... At least two regions of the six members are getting recognised but there are four others and then especially China and some other emerging markets so that industry can only comply with one standard worldwide because we are only selling one product worldwide and don’t want to be forced to follow different standards in different regions of the world.

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Rainier Voelksen will be among the speakers at the forthcoming conference: Software Design for Medical Devices Europe 2013, taking place 29 January - 01 February, 2013 - Munich, Germany. Please visit for details, Contact us on 0800 652 2363 or +44 (0) 20 7368 9300 or email now!

Thank you, for your interest in, Edwards Lifesciences' Rainer Voelksen on Harmonisation of Software Requirements through Standards.
Helen Winsor
Contributor: Helen Winsor