Learn the basic rules and principles of the EU In-Vitro Diagnostic Device Regulation in this free online course. EU IVDR (in-vitro Diagnostic Device Regulation) has been successfully implemented across the European Union. It contains a lot of new requirements and conditions with which manufacturers should comply. In this course, we have included the material that will enable you to help manufacturers achieve the required compliance. This course will teach you about all the essential rules, requirements, and device classifications.
| College | Alison |
| Course ID | 195349 |
| Course Qualification | CPD Certificate |
| Course Duration | 1.5-3 hours |
| Course Fee | Free |
| Entry Requirements | Like all courses on the Alison Free Learning platform this is a free, CPD-accredited course. A Graduate can choose to buy a certificate or diploma upon successful completion of a course, but this is not required or necessary. At Alison we believe that free education, more than anything, has the power to break through boundaries and transform lives. Alison is the world’s largest free online empowerment platform for education and skills training, offering over 5000 CPD accredited courses and a range of impactful career development tools. It is a for-profit social enterprise dedicated to making it possible for anyone, to study anything, anywhere, at any time, for free online, at any subject level. Through our mission, we are a catalyst for positive social change, creating opportunity, prosperity, and equality for everyone. |
| Career Path | What You Will Learn In This Free Course • List the requirements given in the EU IVDR for Notified Bodies • State the IVDR rules used to classify the in-vitro diagnostic devices • Identify the contents of the risk management file of an in-vitro diagnostic device • Explain the notion and the purpose of in-vitro diagnostic devices • Describe all the main requirements that must be fulfilled to get compliant with the EU IVDR • Indicate the major changes brought into the IVDD to convert it into IVDR • List the seven rules of IVDR required to classify the in-vitro diagnostic devices correctly • Outline the requirements for labeling in-vitro diagnostic devices • Distinguish between the In-vitro Diagnostic Directive (IVDD) and In-vitro Device Regulations (IVDR) • Recognize the labels commonly used with in-vitro diagnostic devices |
| Course Code | 7224 |
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