We knew it would happen, and here it is: The latest version of the regulation governing in-vitro diagnostic devices (IVDs) in Europe is available on the EC website [PDF link].
Maurizio Suppo recently wrote a good article about the pending changes in IVD Technology. Maurizio has been around the (IVD) block many times and his perspective is always informed.
According to Maurizio, the update is centered around the Commissions objective "to ensure greater transparency and traceability". As such, the new regulation looks to cover a broader range of IVDs, adapts GHTF-influenced risk-based classifications, and seeks to improve the work of Notified Bodies. (Given the most recent NB scandal, the timing for this is perfect!)
Head on over to IVD Technology for the full article and fasten your seat belt for the drive towards implementation!
[Hat tip to Mel Faux!]
For related information, take a look at the following:
- Preparing for Upcoming Revisions to Europe's IVD Directive (IVDD)
- Who is afraid of clinical data requirements?
- Be prepared – revision of the EU medical device directives
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