EU standards bodies set up new group on software
This article was originally published in RAJ Devices
The European standardisation bodies CENELEC and CEN have established a new group to deal with issues concerning rules on software for medical devices that are due to come into force in the European Union next month1.
The Joint Task Force on Medical Software Standardisation will focus on matters relating to software regulations contained in the Medical Devices Directive (Directive 93/42/EEC) as revised by amending Directive 2007/47/EC, which kicks in on 21 March.
The group is being led by CENELEC and CEN technical committees 62 and 251, respectively. It was inaugurated in December 2009 during a meeting of both committees and CENELEC’s Software and Medical Devices working group, in Brussels, Belgium. It will be led by CENELEC/TC 62 in the first year and by CEN/TC 251 in the second year.
According to discussions at the meeting, the scope of the new group is to:
- monitor the regulatory position related to software in the healthcare domain. This includes medical software (ie software in, or related to, medical devices, which is a medical device in its own right), situations where the regulatory status is not clear (ie borderline) and safety-related matters concerning software used in healthcare IT systems, with the intent of achieving maximum consistency in the approach of European and international standardisation;
- monitor work by other groups, such as the European Commission’s Medical Devices Experts Group, the CEN Advisory Board for Health Standards and notified bodies group NB-MED, and provide advice, proposals and suggestions, whether or not solicited; and
- enable the consistent application of Directive 93/42/EEC (as amended by 2007/47/EC) to software by promoting adequate harmonised standards, specifications and/or technical reports.
The status of guidance/standards and the March deadline
Also discussed at the December meeting was the status of certain guidance documents that are being updated to factor in the new software rules in Directive 2007/47/EC. It was said that the section of MEDDEV 2.4/1 Rev 8 Part 1 (2001) on classification with respect to stand-alone software would be updated before the end of February 2010. However, revisions to other sections of the same MEDDEV document with regards to software will not be ready by 21 March.
It was suggested that the commission’s MDEG ad hoc Software Working Group would also find it difficult to meet the 21 March deadline with regards to completing tasks it had proposed to conduct such as: (1) producing clear definitions and guidance on software and software systems that meet the definitions of the MDD and to which the requirements of the MDD apply; (2) developing a MEDDEV document on software; and (3) conducting an analysis of existing standards relating to software, identifying what gaps or needs exist to develop new standards and seeking a mandate from the commission to develop such standards immediately.
References
1. CEN/TC 251, N09-103rev2, Draft meeting notes, 8 December 2009