;   Medical Translation Insight: Path to updated EU in-vitro diagnostic directive - ForeignExchange Translations

Path to updated EU in-vitro diagnostic directive for medical translationAs 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 for implementing updated IVDD
(timeline from BSI presentation; click for larger version)

For related information, take a look at the following:

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


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