The deadline for manufacturers to mandatorily comply with MDD 2007/47/EC is finally here. As we all know by now, this is a huge milestone after years of planning, reviewing, and an adoption process that started back in 2005. Now, with 5 years in the making, we are finally to the point where medical device manufacturers must comply or face losing their CE Mark as Directive 93/42/EEC is officially amended by 2007/47/EC on March 21, 2010.
There are quite a number of notable changes including the classification of software as a medical device and how this software should be validated. Within MDD 2007/47/EC, there are strict instances as to when software should be classified as a medical device and when it is not. Under Directive 2007/47/EC, because it amends Directive 93/42/EEC, when your software is classified as a medical device, it is subject to the same medical device requirements as under MDD 93/42/EEC.
These requirements include the language requirement of MDD 93/42/EEC under Article 4.4, Annex I, 13.3: “Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, Point 13, to be in their national language(s) or in another community language, when a device reaches the final user, regardless of whether it is for professional or other use.”
For medical devices covered under MDD 93/42/EEC, “information” includes such documentation as Indications For Use (IFU), operators’ manuals, installation manuals, packaging and labeling to name a few. Additionally, for software classified as a medical device under Directive 2007/47/EC, “information” includes GUI (Graphical User Interface), menus, dialog boxes, and error and status messages.
The important thing to remember here is that the explanation that users of the software have an understanding of English will not be acceptable. If the software is classified as a medical device, the user interface needs to be translated, no exceptions.
Additionally, independent of directive 2007/47/EC, software scripts should still be translated into a country’s official language per the Essential Requirements under MDD 93/42/EEC as detailed in a case study involving an industry-leading notified body. The case study can be downloaded here.
With mandatory compliance requirement coming on March 21, there has been a lot of discussion and opposing views. Make sure your software products are compliant to avoid any risk of losing your CE Mark.