On January 27, 2022, the Medical Device Coordination Group (MDCG) published a new guidance document, MDCG 2022-2: “Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)”. This document provides information for manufacturers, regulators, investigators, sponsors, Notified Bodies (NBs) and other industry stakeholders concerning the continuous process for IVD performance evaluation.
The new guidance details how to collect, generate and appraise supporting data for IVDs in regards to Regulation (EU) 2017/746 (IVDR). The guidance covers areas from pre-market through post-market surveillance and post-market performance follow-up for IVD products.
According to Article 56 (1), IVDR EU 2017/746 (IVDR): The manufacturer must specify and justify the level of clinical evidence in view of the characteristics of the device and its intended purpose.
Article 2 (36), EU 2017/746 (IVDR), underlines that the demonstration has to prove via a sufficient amount and quality of clinical evidence, that the IVD is safe, performant* and achieves the intended clinical benefit(s), when used as intended.
The MDCG document clarifies that sufficient clinical evidence is obtained through the use of a systematic and explicit appraisal of data in addition to being updated throughout an IVD’s entire lifecycle**. The clinical evidence demonstration is documented in the performance evaluation plan and report and includes details on the method of data collection. Clinical expertise and judgment are required for the collection and appraisal of data arising from different sources to demonstrate clinical evidence. This assessment relies on the strength, robustness and quality of data according to the principles of evidence-based medicine.
Below, are recommendations from NAMSA based on the new guidance, MDCG 2022-2.
Steps to Conduct Literature Reviews or Other Data Retrieval Methods
- Define a search protocol before commencing data retrieval. The searching strategy must be thorough and objective (i.e. it should identify all relevant favorable and unfavorable data)
- Conduct several searches with consolidated and relevant criteria, or focus in order to obtain all relevant and necessary data
- Ensure appropriate documentation is produced such that the methods can be appraised critically, the results can be verified and searches reproduced if necessary
Evaluating Relevant Data for Scientific Validity, Analytical and Clinical Performance
A) The guideline provides examples of relevant data to demonstrate the scientific validity, the analytical and clinical performance of a device:
- Scientific validity of the device
- Appraised literature data
- Peer-reviewed data
- Published clinical data
- Relevant information on the scientific validity of devices measuring the same analyte or marker
- Proof of concept studies
- Relevant consensus expert opinions/positions from relevant professional associations relating to the safety, performance, clinical benefits to patients, design characteristics, scientific validity, clinical performance and intended purpose of the device
- New evidence generated through clinical and analytical performance studies, or post-market performance follow-up studies
After collecting and/or generating evidence supporting scientific validity, the data and evidence should be appraised, analyzed and documented within the scientific validity report.
B) Analytical performance of the device:
- Data from published experience gained by routine diagnostic testing may be considered supportive evidence to the analytical performance of the device and reported in the analytical performance report
C) The clinical performance of the device (if it applies to the device):
- Data from scientific peer-reviewed literature
- Data from published experience gained by routine diagnostic testing
- Data from clinical performance studies
- Other sources of clinical performance data (include clinical performance studies conducted under the In Vitro Diagnostic Directive [IVDD])
- Data from devices that are claimed to be equivalent to the device under assessment
After collecting and/or generating evidence supporting the clinical performance of the device (where applicable), the data and evidence are appraised, analyzed and documented within the clinical performance report.
* In conformity with the applicable general safety and performance requirements (GSPRs).
** MDCG proposes a table in Appendix II that highlights the required frequency for updates of reports based on device class and type of document.
How Can NAMSA Help?
With over 40 medical writers worldwide, NAMSA provides a wide range of specialized report writing, manuscript submission and evidence communication services. Our medical writing team is expert at identifying, organizing, interpreting and presenting clinical data in an accurate and professional manner that is highly recognized and trusted by medical device manufacturers and global regulatory entities. The team is also experienced and skilled in defining and prioritizing which reports are required to comply with the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), MEDDEV 2.7.1 rev. 4, NMPA regulations and a multitude of other regulatory guidelines.
To learn more about NAMSA’s medical writing expertise, please visit us at: https://namsa.com/services/medical-writing/, or request a complimentary consultation with one our experts today: https://namsa.com/namsa-expertise/subject-matter-experts/.
Lucile has been in the industry for over 6 years with 4 years focused on IVD. Lucile gained experience on IVD product development (laboratory-developed test, LDT) in a clinical lab in USA. She designed infectious disease molecular diagnostic assay, developed clinical contents and was responsible for clinical interpretation of the test results. She was also involved on maintaining pharmacogenetics existing LDT through literature search and guideline updates for example. She trained clinical and sales force teams on the scientific, clinical and technical aspects of the LDTs. Lucile was a Project Lead in R&D and a Manager of in vivo studies for a biotechnology company in France before joining NAMSA. As a Project Lead in R&D she designed and led several gene-editing projects and she managed internal and client in vivo studies. Lucile holds a BSc degree in Cell Biology and an MSc & PhD in Developmental Biology from Mediterranee University, Marseille, France. She also performed a postdoctoral training in cardiovascular research at University of California, San Diego, USA. She successfully secured five fellowships and has won two awards for her academic research.