No Free Pass: Why Most Self-Certified IVDs Must Comply with the EU IVD Regulation 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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Writing NPS Protocols and Testing for Medical Device Manufacturers

This is the last article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient PDF. Part 1: NPS Risk Assessment for Medical Device Manufacturers Part 2: Non-Product Software (NPS) Validation for Medical Device Manufacturers Part 3: This article There’s a lot of preparation involved in validating non-product software, and the actual testing is just one of many activities. Much like other technical testing activities, well-executed testing is completely dependent on […]

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Non-Product Software (NPS) Validation for Medical Device Manufacturers

This is the second article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient PDF. Part 1: NPS Risk Assessment for Medical Device Manufacturers Part 2: This article Part 3: Writing NPS Protocols and Testing for Medical Device Manufacturers   Compiling a comprehensive list of all non-product software (NPS) and conducting an initial risk assessment are critical first steps in the validation process. While low-risk software likely won’t require a […]

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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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