Document by year end to shed light on medtech software work
This article was originally published in Clinica
There is a proliferation of work globally on software standards and a need to bring more awareness to what is available to this area, especially with a view to helping manufacturers of medtech products containing/making use of software meet the latest EU requirements.
In the light of this, and with stricter software requirements about to take effect in the EU as of March 21 2010 as a result of the revised Medical Devices Directive (
This is one step that is being taken towards advancing work on medtech software issues.
There are also plans to set up a European Commission working group at MDEG level that will deal specifically with such matters. Candidates have been nominated to be on this group.
It is not just manufacturers who will benefit from this work.Regulators in the EU and globally also have an interest in being informed, and the material will also be fed into organisations, such as NB-Med, which writes medical device guidance documents.
Paper ready by year end
This medtech software overview paper will be ready by the end of the year, Peter Linders, chair of Technical Committee (TC) 62 of the European electrotechnical standardisation body, CENELEC, told Clinica. (CENELEC writes standards for electrical equipment in medical practice and Dr Linders is director of standards and regulations at Philips Healthcare.)
A Software and Medical Devices (SAMD) working group was set up towards the end of 2008 within TC 62 for this purpose.
Under the so-called Dresden agreement, when identifying its requirements for new work (including the revision of existing standards), it is the policy of CENELEC to ascertain first whether the International Electrotechnical Commission (IEC) can undertake this work and whether CENELEC members are directly involved in the planning of new work in the IEC in their capacity as IEC members.
In other words, CENELEC does not draft standards unless there is a specific mandate to do so. All Europe's needs for standards proposals tend to be delivered by the IEC.
The SAMD is also monitoring from CENELEC's perspective the work on e-health interoperability, which is being carried out under European mandate M/403, issued in 2007 by the European Commission to European standardisation organisations CEN, CENELEC and ETSI to develop a co-ordinated work programme for standardisation in health informatics. The group aims to work closely with the CEN/TC 251 Health Informatics.