Difference between IVD and IVDR
In Vitro Diagnostics (IVD) and the In Vitro Diagnostic Regulation (IVDR) represent distinct regulatory frameworks for medical devices. IVD refers to diagnostic tests conducted outside the human body, such as blood tests or genetic assays. The IVDR is a European Union regulation that replaced the In Vitro Diagnostic Directive (IVDD) and imposes stricter requirements on the manufacturing, testing, and performance evaluation of IVDs. It introduces enhanced scrutiny of diagnostic devices, emphasizes risk-based classification, mandates greater clinical evidence, and enforces post-market surveillance. The IVDR aims to ensure the safety, efficacy, and quality of in vitro diagnostic medical devices in the EU market.
New updates in EU IVDR regulation
- Extended Transitional Periods: The most significant update is the staggered extension of deadlines for complying with the IVDR. This aims to address concerns about potential shortages of essential in vitro diagnostics.
- High-risk devices (Class D) now have the deadline until December 31, 2027
- Medium-risk devices (Class C) have the deadline until December 31, 2028
- Lower-risk devices (Class B and A) have the deadline until December 31, 2029
- Guidance Documents: The European Commission has published several updated guidance documents to clarify various aspects of the IVDR. These documents cover topics like:
- Classification of borderline and specific devices
- Responsibilities of importers and distributors
- Vigilance terms and concepts
- European Union Reference Laboratories: The Commission has designated specific laboratories to support the implementation of the IVDR by providing expertise and technical assistance.
What countries follow IVDR
The IVDR is directly applicable in all 27 European Union member states (EU). Additionally, it applies to the following countries:
- Iceland
- Liechtenstein
- Norway
- Switzerland
These countries and the EU form the European Economic Area (EEA). While not formally EU members, they follow the EU's regulations for the free movement of goods within the single market.
It's important to note that the UK no longer follows the IVDR after withdrawing from the EU.
Example of an IVDR
An IVDR itself isn't a specific document, but rather a regulation outlining the requirements for in vitro diagnostic devices (IVDs) placed on the European market. However, due to the dynamic nature of regulations, there are various documents associated with the IVDR, such as:
- The IVDR Regulation (EU 2017/746): This is the core legal document outlining the essential principles and general requirements for IVDs. It defines the classification rules, conformity assessment procedures, and obligations of manufacturers, importers, distributors, and other stakeholders.
- Commission Implementing Regulations: These regulations provide further details on specific aspects of the IVDR, such as:
- Classification rules: These rules define the criteria for classifying IVDs into risk classes (A, B, C, and D).
- Conformity assessment procedures: These procedures outline the different routes manufacturers can take to demonstrate their device's compliance with the IVDR.
- Guidance documents: These non-binding documents clarify various aspects of the IVDR and its implementation.
- Standards: While not mandatory, harmonized standards published by recognized organizations can help manufacturers demonstrate compliance with the IVDR's essential requirements.
Does IVDR apply to clinical trials?
The IVDR can apply to clinical trials, depending on the specific circumstances. Here's a breakdown:
IVDR applies to:
- Investigational tests with a medical purpose: If a clinical trial uses an in vitro diagnostic test (IVD) to guide medical decisions for European patients within the trial (e.g., patient selection, treatment allocation, safety monitoring), the IVDR applies to that specific test. This includes:
- Tests were developed in-house for the trial.
- CE-marked IVD kits are used off-label (for a purpose not listed on the CE marking).
IVDR does not apply to:
- Investigational tests without a medical purpose: Tests used solely for research purposes and don't influence patient management are not subject to the IVDR.
- Clinical trials outside the EU: The IVDR only applies to tests used in clinical trials involving EU patients or conducted within the EU.
