The new In vitro Diagnostics Regulation (IVDR) radically changes requirements for In Vitro Diagnostic Devices (IVD) and represents a major challenge for all parties involved. In particular, manufacturers face a high level of uncertainty and the transition from the In vitro Diagnostic Directive (IVDD) to the IVDR can seem almost impossible.
PlantVision has an experienced multidisciplinary team, covering a broad range of resources, expertise, and services, who can provide customers with continuous support over the implementation and transition period to IVDR.
Support for transitioning from IVDD to IVDR
The IVDR has introduced a new risk classification system compared to the IVDD, which is based on a set of risk levels and classification rules. This also entails changed requirements for most IVD products.
Compared to the IVDD many manufacturers will find themselves confronted with significant gaps in their documentation and they will face inspection by a notified body for the first time. Even other actors in the supply chain, such as distributors and importers, as well as hospital laboratories, will experience more scrutiny and new requirements to fulfill.
Regardless of your role within the IVD industry, PlantVision can help you on your IVDR journey.
For starters, PlantVision can help your organization to gain a good understanding of the new regulation and its requirements. This can be achieved through tailormade courses or workshops, where we help you to identify your company’s specific needs. Alternatively, you can look out for our PlantVision Academy courses. Follow us on LinkedIn to stay up to date regarding available courses and conferences on the subject.
PlantVision can also help you to efficiently define your transition plan by carrying out a thorough IVDR gap analysis, providing a detailed follow-up report with recommendations for what actions should be taken. Our consultants have broad industry experience, as well as in-depth knowledge about IVD’s. We can help with risk, quality and regulatory management.
Through both strategy and resources we can help smooth the path to a CE marked product – from requirements, development, documentation and tests, to contacts with Notified bodies and market access.
You can also ensure continuous support through our QA/RA Partner service, which provides fast and efficient access to experienced consultants especially during your transition period.
At your service
All of our IVDR solution areas can be customized to meet your company’s specific needs:
– “Getting started” seminar & workshop
– Gap analysis
- Gap analysis workshop
- Transition plan IVDD – IVDR
– Customized RA support during transition process (QA/RA Partner service), e.g…
- Applying for notified body
- Reviewing your quality management system
- Clinical evaluation strategy and reporting
- Guidance in planning your post market surveillance system
– PlantVision Academy courses and customized training
Contact me to find out more about how we can support your organization, or continue reading about IVDR below…
Arrange a free TWO HOUR seminar & workshop with our IVDR specialists. We will visit your company and introduce you and your colleagues to the changes ahead. During the workshop we will help you to identify the specific challenges your organization faces as it transitions to IVDR.