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.
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The outcome of a survey by trade association MedTech Europe shows that while more than 90% of companies benefited from the extension of IVDR transition deadlines, significant issues remain that could see many diagnostics disappear from the market.
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.
When Is An IVD A CDx? EU IVDR Guidance Updated To Include Flowchart
The EU Medical Device Coordination Group has issued a second revision to its guidance document on classification rules for in vitro diagnostics under the new regulation. The addition of a flowchart to determine when an IVD is a companion diagnostic is one key change.