Medical Translation Insight

As we noted before, major revisions are coming to the European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD). Two-and-a-half years after the updated MDD and AIMDD took effect, we are getting a little closer to the next iteration of the IVDD as well.

medicaldeviceslegal recently had a good summary of the changes that are likely to be included in the updated directive, highlighting the following three:

1. GTHF approach to classification
2. Clinical substantiation
3. Increased measures for post market surveillance

Notably absent, at least at this stage, are any changes affecting language or translation. But actual implementation is still several years away and a lot can happen between now and then!


(timeline from BSI presentation; click for larger version)

For related information, take a look at the following:

• Preparing for Upcoming Revisions to Europe's IVD Directive
• Who is afraid of clinical data requirements?
• Be prepared – revision of the EU medical device directives

ForeignExchange Translations provides specialized software localization and regulatory translation services to medical device and IVD companies. Contact us to learn more.