The European Medical Devices Regulation (EU MDR) is a new set of regulations that govern medical devices’ production and distribution in Europe, effective May 26, 2021. The EU MDR requires more stringent clinical evidence for medical device manufacturers than previous guidance (Directive 90/385/EEC, Directive 93/42/EEC). As a result, many medical device manufacturers will need to collect more evidence proactively via clinical investigations or other post-market clinical follow-up (PMCF) activities to obtain and renew their Conformitè Europëenne (CE) Mark certifications.
The proactive collection of clinical data throughout the lifetime of the device is an incredibly daunting and expensive requirement. Device manufacturers must determine which PMCF activity or activities will be appropriate for their device type and classification to ensure the data generated will satisfy MDR requirements and Notified Body (NB) scrutiny in audits.
Where enough clinical evidence exists, device manufacturers can leverage PMCF Survey options whenever possible as it provides significantly faster results at a significantly lower cost compared to registries and clinical investigations.
Collecting high-quality data is the goal for any clinical study, and PMCF studies are no exception. The key is to rely on excellent guidance and sound technology. Since PMCF can include data from various sources, manufacturers should include exact steps for data capture that comply with EU MDR requirements and the respective authorities.
Cetas Healthcare has extensive experience helping European medical device manufacturers with high-quality data capture to comply with EU MDR and other regulations. Our team of experts can help you design and execute your PMCF Surveys! Check out our PMCF Surveys services for more information.
Our PMCF studies can be completed in 8-12 weeks
Submitted 3000+ patient forms to NB in 2022 till date
Our PMCF studies surveys cost ~90% lower than clinical trails
Own panel of 4 million pre-qualified and recruited HCPs
A team of 75+ MedTech experts,one of the largest agency globally.
Protocol Design: Designing a protocol including sample size requirements and getting the protocol approved by the relevant notified body
Better Quality : Manufacturers should comply with Good Clinical Practice (GCP) for clinical investigations and PMCF studies. In Europe, the International Organization for Standardization (ISO 14155) sets the rules for conducting clinical investigations. Cetas Healthcare team follows the required standards for PMCF survey protocol design and data collection.
Strong Team : Cetas Healthcare has a team of clinical experts who have extensive experience with MedTech companies in designing protocols for clinical studies, registries, etc.
Access to notified bodies : Cetas Healthcare has relevant expertise and access to Notified Bodies to ensure the PMCF protocols meet the regulatory requirements.
Data Collection : Survey programming and data collection from the required HCPs from specific geographies in a compliant platform
Pedigree : Over the last 10+ years of data collection for market research surveys in the MedTech space, Cetas Healthcare has built robust processes and protocols to ensure seamless execution of highest standards of data quality. Cetas Healthcare has leveraged this core expertise for data collection for PMCF surveys.
Access to Clinical Stakeholders : We have access to ~4Mn Healthcare professionals including various type of clinicians, nurses, and other allied healthcare professionals across 75+ countries globally. Owing to our pedigree in data collection and our access to the HCPs, we offer smooth enrollment of sites for PMCF surveys.
Speed : Weeks instead of months/years. Once the protocol is agreed with our clients/study sponsors, it takes a week to program the survey and 4-6 weeks to gather data from HCPs based on the sample size requirements as per the study protocol.
Quality : We have access to technology platforms to capture and store the survey data that are GCP, ISO 14155 and GDPR compliant to ensure best clinical practices and highest data security of the PMCF surveys.
Cost : Less than 1/10 of the cost of a clinical study or registry
Report preparation : Data/statistical analysis using a validated software program followed by the final report document to be submitted to the respective notified body
Strong team : Cetas Healthcare has an in-house team of RA Experts, Biostatisticians and Data analyst with strong experience in conducting PMCF surveys, analyzing in clinical study and submitting reports to notified bodies.
Access to tools/software : Cetas Healthcare has access to the appropriate statistical tools and softwares to conduct the analysis and prepare the final report for submission to the relevant notified bodies.