Similar to the EU Medical Device Regulations (MDR), the new In-Vitro Device Regulations (IVDR 2017/746) are set forth to increase patient safety. To successfully transition to the new regulations, manufacturers need to prepare their products and processes for increased oversight, greater transparency, and more robust documentation and reporting. In this article, we'll address commonly asked questions surrounding IVDR.
How is IVDR different from the existing IVDD?
Generally speaking, the new In-Vitro Diagnostic Device Regulation (IVDR) aims to increase patient safety by implementing the following:
- Life Cycle Approach: IVDR puts a spotlight on a manufacturer’s QMS by requiring more thorough and transparent documentation and maintenance. Given the new risk-based approach and emphasis on the continual evaluation of a device, manufacturers need to make sure their processes, procedures, and technical documents are in place. Conformity includes (but is not limited to) an effective quality management system and a system of "living documentation" proving post-market performance.
- Re-classification: Instead of the existing list-based classification, IVDR regulations employ a rule-based system, aligning products into four classes based on risk ranging from Class A (lowest risk) to Class D (highest risk). Class D devices fall completely under IVDR and require a higher level of involvement from a notified body.
- Notified Body Review: CE marking a medical or in-vitro device is required in order to sell devices in the European Economic Area. To achieve CE marking, devices in Class B or higher must now be approved by a separate, authorized entity, or Notified Body, who is overseen by a competent authority. The increased oversight is intended to remove individual interpretation of the guidance provided in the existing directive.
When does IVDR go into effect?
IVD manufacturers who market their devices in Europe have until May 26, 2022 to transition to IVDR. As the deadline draws near, Notified Bodies face a tremendous volume of work and the review process may be lengthy. With just a few years to go, many device manufacturers have begun their transition to ensure their products stay on the market.
What is considered "living documentation?"
Living documentation is an approach used to consistently prove that a device is safe and consistent with state of the art. Performing annual updates will be a required step for higher risk devices such as those in Classes C and D. Examples of living documentation include:
- Periodic Safety Update Reports (PSURs)
- Post-market surveillance plan
- Post-market clinical follow-up plan
What’s a Performance Evaluation Report (PER)?
A Performance Evaluation Report, or PER, is the IVDR’s version of the Clinical Evidence Report (CER) as described in EU MDR MEDDEV 2.7.1 Revision 4. Just like CERs, PERs are a critical step in the CE marking process. Read more on these blogs:
Do I have the right regulatory team on staff?
Per Article 15, IVD organizations must designate a Person Responsible for Regulatory Compliance, or PRRC. Experience in IVD regulations, QMS, and IVD manufacturing is crucial to the position of the PRRC, since he/she is responsible for conformity, document maintenance, and reporting to the authorities.
Are you faced with IVDR 2017/746 compliance?
Leverage our trained experts as part of your compliance game plan.