An evolution in the definition
With the EU Medical Device Regulation (MDR) update, the manufacturer is now required to “proactively collect and review the experience gained from the devices it places on the market”. This is mandatory.
This change brings under control a step that previously couldn’t be monitored in a consistent way. The MDR aims to structure product monitoring over the entire life cycle and to reduce patient risk as much as possible. It requires the implementation of a Post Marketing Surveillance (PMS) plan.
Class 1 devices (see our article – New Medical Devices Classification) must provide a Post Marketing Surveillance Report (PMSR) where Class 2A, 2B and 3, products are required to provide Periodic Safety Update Reports (PSURs)
The objective of implementing a PMS plan is to increase the safety of the products marketed and to ensure a durable CE marking.
One of the components of a PMS plan is the PMCF study and the data collection in real-use conditions.
Implement a PMCF study into your PMS plan
Setting up a PMCF (Post-Market Clinical Follow-up) study aims to ensure the medical device’s real-life performance and safety claims over time.
In PMCF studies, all data collection activities, documentation, and performance evidence are detailed. The PMCF should provide figures on the number of patients using the device, the inclusion criteria, the follow-up period, and the evaluation criteria.
Regulations to take into account
The regulation doesn’t specify a precise format for conducting your PMCF studies. You can conduct conventional clinical studies, use literature and scientific resources, or conduct surveys involving professionals or patients. As these guidelines may seem confusing, choosing the right tool and partner to conduct your PMCF studies is best.
These studies can be carried out through EDC solutions such as Datacapt, including ePRO questionnaires that will provide insight into the device’s safety and effectiveness directly through patients.
The benefits of implementing PMCF studies for your company
More than an obligation, the PMCF study is an opportunity to collect data from end-users (patients/doctors/medical team …) with the aim of improving and monitoring the products.
Ensure the sustainability of your product over time through continuous improvement.
Know your product users and targets better.
Better engage with your patients as they are being consulted.
Implementation of a new version.
Set up your PMCF studies with Datacapt
By complying with all the regulations in force, Datacapt enables you to collect quality and secure data.
Our different modules are perfectly aligned with the EU MDR standard for PMCF studies, allowing you to collect real-life data directly from your patients/users (simple access and 100% web-based).
The use of Datacapt modules will allow you to maximize your on-site, hybrid, and/or remote data collection.
Also, take advantage of ePRO by sending questionnaires to patients, healthcare professionals, or any other actor before (baseline data) during, and/or after the use of the product.
With Datacapt, simplify your life.
Focus your teams’ efforts on the success of your studies and the marketing of your products.
New European Medical Device Regulation (EU MDR)
Understand the main changes in the EU MDR regulation and its implications for your clinical studies.
Read this article to see the most important changes.
ePRO, why will electronic questionnaires become the rule?
Patient questionnaires (ePRO) are one of the solutions available for conducting PMCF studies under the new EU MDR regulation.
Read this article to discover the full benefits of Datacapt ePRO.
Simplify your medical device and PMCF studies with Datacapt.
With Datacapt, you can benefit from flexible, regulatory-compliant electronic data capture solutions. We are here to assist you in improving your compliance with the EU MDR.
