Written by: Jasmin Hunter, Senior Consultant
The European Commission (EC) released an update on the EU MDR 745/2017 readiness survey (6th NB survey) in March 2024 that shows a steady increase in product applications and MDR certificates for medical devices, with almost 40% receiving certificates by the 31st of October 2023. The biggest reasons for refusal were found to be that the application was outside the scope of the notified body’s designation (40%) or the application was not complete (24%). Timelines for assessments are long. In most cases 6 – 12 months for low-risk devices (class IIa and IIb) and 13 – 18 months for class III devices.
Qserve is very focused on making sure our clients have as smooth of a transition to MDR as possible. We are pleased to share our rates of success for clinical evaluation approval and tips on how to ensure manufacturers can avoid refusal due to the application not being complete. Particularly for clinical aspects as these can be the costliest and time-consuming requirements for MDR compliance. We’ve seen many applications delayed due to incompleteness. At times stretching out beyond the 18-month timeline if there is insufficient data. In these cases, Qserve provides guidance on cost-effective and time-efficient clinical data collection strategies to keep things on track.
We have conducted a review of applications that Qserve has worked on, either writing the clinical evaluation, providing support for specific aspects of clinical data analysis, or answering Notified Body (NB) questions. We have found that 76% of class III applications complete the clinical review in 2 rounds of questions and 24% in one (1) round. Class IIb active devices or software complete the clinical review in 2 rounds in 100% of cases. 16% of class IIa devices complete clinical reviews in one (1) round and 83% in 2 rounds.
The ability to achieve clinical compliance in one round depends on the quality of the data and the ability to support each device variant including accessories. It was necessary to adjust claims concerning lifetime in 45% of cases to match clinical data already available. In those cases, we were able to identify suitable data in literature to extend the lifetime claim as much as possible. In rare cases, we have seen a biased preference for particular devices from the clinical expert that focuses on negative data from literature despite the presence of positive data. If there are multiple treatment options, it is possible the clinical reviewer has a preference. Some Notified Bodies will guide clinical experts on what is sufficient from a regulatory perspective, effectively eliminating this bias. If this is not done, Qserve has been successful debating personal opinion over regulatory requirements with NBs.
The most important element of clinical evaluation is the appropriateness of the endpoints (or clinical outcome parameters) selected to characterize the performance and safety of the device. In all cases, Qserve and Qserve CRO can guide you on the best endpoints to use from literature with a focus on similar endpoints for other post-market clinical follow-up (PMCF) activities to make analysis more straightforward. We have found that Notified Bodies do compare complaint rates and endpoints from similar devices and will use this as a guide for in-depth questions on the device under evaluation.
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 CRO’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 support 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. Our team is ready to assist you – schedule a free introductory call today to get started.