COVID-19

Performance Evaluation

The MDCG 2021-2 guidance provides a set of definitions to complement those given by the IVDR, especially for the terms referred to in Annex I, 9.1 (a and b), which include both analytical performance (i.e., limit of detection, analytical specificity) and clinical performance elements (i.e., diagnostic sensitivity, specificity). Interestingly, this MDCG also defines terms not previously found in the IVDR (i.e., robustness, whole-system failure), harmonising novel performance characteristics required for SARS-CoV-2 IVDs.

As a general consideration included in this guidance, manufacturers are now asked to conduct the performance evaluation by comparing their devices with state-of-the-art and CE-marked IVDs with equivalent performance characteristics. 

SUMMARY OF SERVICES

• Analytical performance studies
• Clinical performance studies
• Usability studies

Samples of the European population

One of the most challenging requirements introduced by the guidance is the necessity for manufacturers to perform the SARS-CoV-2 IVDs Performance Evaluation on a population equivalent to the European population. In other words, manufacturers who used non-equivalent samples for performance studies are asked to address it now with samples equivalent to those of the EU members.

Batch Verification and self-tests

• MDCG 2021-21 sets the expectation that the manufacturer’s batch testing criteria should ensure that every batch identifies the antigens, epitopes, and antibodies for which the IVD is suitable. 
• Guidance also establishes that self-testing IVDs should meet the same sensitivity and specificity requirements as those IVDs for professional use.
• In addition, usability testing should include laypersons to ensure that the device is safe for the final user and that the instructions for use (IFU) are clear.

Specific requirements for each type of test

• Seven tables of specific considerations to determine the analytical and clinical performance of each type of SARS-CoV-2 IVD test are introduced in MDCG 2021-21.
• We encourage manufacturers to go through the guidance document and check which requirement applies to their IVDs.
• For certain IVD types, additional requirements such as seroconversion panels or whole system failure rates from low-positive specimens within the risk analysis of the device apply.
• In addition, the guidance establishes a notable increase in sample sizes for determining performance characteristics.

Ethics Committee and Regulatory Submissions

SUMMARY OF SERVICES

• Clinical Investigation Protocol (CIP) Development
• Informed Consent Form (ICF) Development and Review
• Clinical Trial Application Support
• Essential Clinical Site Start-up Activities

KEY THERAPEUTIC AREAS AND PRODUCTS

• Hyperbaric Oxygen Therapy (HBOT) | Hydrogen-Oxygen Generator|CPAP machines
• Patient Monitoring condition software | Telerehabilitation platforms | Telemedicine platforms
• Biosensors
• Medical Masks
• ECMO | Blood filters

Technical documentation

SUMMARY OF SERVICES

• Preparation of Clinical Evaluation (CER) and Performance Evaluation (PER) Reports
• Manage compilation of technical documentation
• Ensures adequacy of regulatory documents and compliance with EU MDR and IVDR requirements. 
• Maintaining client and internal documentation in accordance with established SOPs
• Ensuring project/contract obligations are met in a timely manner