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:
- GTHF approach to classification
- Clinical substantiation
- Increased measures for post market surveillance
(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
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