TEAM-NB Paper Offers Guidance For Manufacturers On IVDR Technical Files
What do notified bodies designated under the EU In Vitro Diagnostics Regulation expect to see in manufacturers’ technical documentation during conformity assessments? A new TEAM-NB position paper helps companies through this process.
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Trade Body Updates Guidance On Meeting IVDR Clinical Evidence Requirements
Fulfilling performance evaluation obligations under the EU In Vitro Diagnostics Regulation can be confusing for manufacturers and particularly SMEs. Trade body MedTech Europe explains why defining the intended purpose of a product is a good place to start.
Another Notified Body Designation Coming Down The Line Under The EU MDR
With two IVD Regulation notified body designations in the last week, there should be one more notified body listed under the Medical Device Regulation designation shortly. But then there is likely to be a gap.
Total Number Of IVD Regulation Designations Reaches 10
Two EU IVDR notified bodies have now been designated this week. NSAI of Ireland has been designated as a notified body under the IVD Regulation, the tenth under the EU’s IVDR, and is specializing in self-testing.