As we enter a new phase of the Medical Device Regulation EU 2017/745 (MDR) transition and shift focus from legacy devices to placing new devices on the market, it is time to reflect on knowledge gained from over 2-years of responding to clinical reviewer questions. In short, reviewer questions have followed the requirements put forth in MDCG 2020-13. This guidance document specifies a Clinical Evaluation Assessment Report (CEAR) template for notified bodies (NBs) that is to be filled out in detail during the audit of a clinical evaluation. A clinical evaluation is required by MDR Article 61 for all medical devices seeking CE mark in the EU. While there has been variability in interpretations of some of the requirements amongst NBs, the template in large part keeps most reviewers focused on key aspects required for systematic literature reviews and sufficient clinical evidence assessments that were not always scrutinized under the MDD. The result is a wide array of questions related to the clinical evaluation, IFU, marketing material, SSCP, and PMCF documents that manufacturers struggle to answer.
NB queries may require a tight timeline for response and an update of the clinical evaluation documents especially with multiple technical file reviews taking place in a short period of time. The responses require dedicated resources including a resource with clinical knowledge on the use of the device, associated medical field and proper documentation for a systematic literature review. There are typically three chances to get the answers correct. However, if the NB does not feel the question can be answered based on the responses given there is a risk of clinical evaluation non-compliance which is recorded in the CEAR and results in additional scrutiny once the updated documents are submitted as a new application. This increases the timeline for certification.
An overview of the types of NB questions that arise from a class III device is provided below. While the number of questions for class IIa and IIb devices is often about a third of the number for class III devices, the questions are just as detailed. The driving factor in the number of questions stems from the adequacy of the safety and performance objectives chosen to evaluate the device under evaluation. Safety and performance objectives may also be referred to as “clinical outcome parameters” or “endpoints”. Each of these terms describes the type of data that is extracted from literature, collected as part of clinical investigation, or PMCF activity. Questions relate to justifying acceptance criteria based on literature from similar devices or other state-of-the-art information. If there is uncertainty around this aspect or if the device under evaluation differs from the acceptance criteria, more questions will arise concerning related aspects of PMCF, SSCP, clinical evidence, and labeling. Specific citations may be identified by the NB and challenged in relation to the safety and performance objectives. These challenges often lead to concerns in data gaps.
Overview of Questions for a Class III Device
Questions are effectively answered with strong scientific justifications for the objectives and acceptance criteria selected. A more detailed analysis of selected citations may be necessary if this analysis was not presented in the CER. Additional literature to support any gaps or concerns from the NB may also be necessary.
Qserve’s Notified Body-like Review service can help prepare your clinical evaluation for a smooth audit and reduce the risk of non-compliance if there is sufficient data. Qserve’s expert team of clinical writers and auditors can provide;
- A clinical evaluation gap assessment based on CEAR outlined in MDCG 2020-13,
- Sufficient clinical evidence assessment based on clinical claims, indications and intended purpose of the device,
- Recommendations on cost effective and time sparing clinical data collection, if applicable through our full service CRO,
- NB query responses that limit the number of question rounds,
- Comprehensive Systematic Literature reviews,
- Clinical outcome parameter selection and documentation for literature data extraction, clinical investigations or PMCF surveys, and
- Full clinical evaluation remediation.
Do not hesitate to contact us for help with your clinical data.
Read part I of this series here: Understand the Challenges | Common Pitfalls to Avoid in Technical Documentation under the Medical Device.