How to avoid delay and non-compliance of your PMCF activities
With full MDR implementation less than 1 year ahead, the active collection of clinical data from the use of your device probably has your full attention. PMCF plans are under development, or even better already implemented. You were one the right track, and now COVID-19 has ruined your plans. At Qserve we believe in the practical approach; clinical data collection during a pandemic is not an impossible task! Let’s look at the opportunities.
For many medical devices on the market, post-market clinical data collection is needed to enable CE-marking under MDR. Many clinical activities (studies, registries) running at hospitals have been postponed or suspended, due to the COVID-19 pandemic. Even with the MDR’s date of application postponed to 26 May 2021, delays could result in insufficient clinical evidence by the time your MDD CE-certificate expires.
Fortunately, clinical studies and hospital-based activities are not the only method of clinical data collection. Depending on the clinical data gap to be addressed, post-market clinical follow-up (PMCF) surveys can be a valuable data collection tool. User surveys (collection of feedback from users) are a valid PMCF method. PMCF surveys can be performed fully remotely without site visits, nor patient contact.
Advantages of PMCF surveys:
- Fully remotely
- Low costs
- No approvals required
- High-quality surveys result in high-quality data
- Sufficient clinical evidence, meeting PMCF requirements
High-quality surveys result in high-quality data, where low quality survey end up having no regulatory value. Survey development requires knowledge and experience. Survey design, endpoints, acceptance criteria, regulatory requirements, operational excellence, compliance and biostatistics are the recipe for success.
Clinical evidence has to be of a sufficient amount and quality. It is important that both the design of the survey and its implementation and execution are of the highest possible quality. Using an Electronic Data Capture (EDC) system increases data quality.
At Qserve we can help you develop and implement custom made surveys for your device, and we can help manage the expectations with the NB, especially considering COVID-19 limitations. Please send us an email or give us a phone call to discuss the possibilities.