IVD Clinical Evidence Needed for IVDR Performance Evaluation Reports. Where to Begin?

In vitro diagnostics (IVDs) are a tiny fraction of overall healthcare costs, but they play a large role in patient diagnosis and decisions that greatly impact patient care. While medical devices can cause physical harm to a patient or user through direct impact, IVDs can also inflict indirect harm through improper diagnosis or patient care caused by incorrect results. Regulators in Europe realized that a much wider product offering of IVDs needed to be held to the same standard as […]

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The Importance of Properly Grouping IVD Registrations Under the EU IVDR

The European In Vitro Diagnostic Regulation (IVDR) takes hold in May 2022. When that happens, 80-90% of all IVDs will require CE certification by a Notified Body, up significantly from what was required under the In Vitro Diagnostics Directive (IVDD) (i.e., 10-20%). That enormous expansion has caused widespread heartburn in the industry, especially among those unfamiliar with strict new IVDR requirements. Classification of IVD Devices Under the IVDR The In Vitro Diagnostic Regulation (EU 2017/746) groups products according to risk: […]

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No Free Pass: Why Most Self-Certified IVDs Must Comply with the EU IVDR by May 2022

The new European In Vitro Diagnostic Regulation (IVDR 2017/746) goes into effect on May 26, 2022. At that time, 80-90% of all IVD manufacturers will be reclassified to Class B or higher and therefore require an audit by a European Notified Body approved to conduct audits for IVDR compliance (see current list). While manufacturers of List A and B devices under the In Vitro Diagnostics Directive (IVDD 98/79/EC) are accustomed to the rigors of a Notified Body audit, they are currently […]

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The Role of Medical Device Economic Operators in Europe

Authorized representative. Importer. Distributor. Person Responsible for Regulatory Compliance. The new European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) certainly keep regulatory professionals on their toes. The duties associated with these four roles are outlined in Articles 11, 13, 14, and 15 of both regulations, respectively. However, they can be somewhat confusing because there is significant overlap in what some of these so-called “economic operators” do. In this article, we will give you a rundown on what […]

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