In vitro diagnostics (IVDs) are clinical tests that analyse samples taken from the human body. These tests can detect disease, conditions, and infections. In vitro testing can be carried out at labs, hospitals, or even patients’ homes. The tests themselves can be performed on various instruments, from small, handheld tests to complex laboratory instruments. They enable medical professionals to accurately diagnose patients and conduct the most effective treatments.

What do you need to be compliant?

The EU IVDR makes significant changes such as the new product classification system, and the requirement that manufacturers of IVD devices (Class A exempted) must consult a Notified Body for approval.

To successfully transition to IVDR and be fully compliant, manufacturers must prepare reliable documentation of performance, high safety standards and effective risk management, in addition to conducting comprehensive product inspections while on (and prior to entering) the EU markets.

A thorough evaluation of the in vitro device’s performance is essential for IVDR compliance. The performance evaluation is a continual process that demonstrates an IVD’s analytical and clinical performance, as well as its scientific validity.

How can Clin-r+ help?

Our team recognises that the transition from IVDD to IVDR is not a straightforward one. CLIN-r+ has the knowledge and expertise to provide dedicated IVD support. This could be for anything from undertaking a gap assessment or compiling specific documents to putting together the overall technical documentation structure with you. Our strategic approach has positive impacts and helps businesses succeed.

We consider how the IVDR requirements will impact our clients including Notified Body engagement, classification assessment, QMS impact, GSPRs, risk management, performance evaluation, technical documentation, economic operators, labelling and post market surveillance.

CLIN-r+ can support you to create your Standard Operating Procedure and create a comprehensive Performance Evaluation Plan (PEP). Our team has the industry and regulatory expertise to ensure that the key elements are considered and included in your PEP and Performance Evaluation Report (PER).

Leveraging CLIN-r+ experience in creating EU IVDR compliant Technical Documents will not only obtain your CE mark but also makes it easy to maintain your paperwork for audits. Clin-r+ has created hundreds of technical documents across all device classes. We align with your Notified Bodies processes and checklists to make sure you get it right, first time!

Need more details?

We are here to assist. Contact us, set up a meeting, join our mailing list or follow us on LinkedIn.

You can also check out these white papers on our MedTech Academy:

• IVD Performance Evaluation