The EU Medical Device Regulation (EU MDR) is a new set of regulations that govern medical devices’ production and distribution in Europe. 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 post-market clinical follow-up (PMCF) activities to obtain and renew their Conformitè Europëenne (CE) Mark certifications.
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 a PMCF Report can include data from various sources, manufacturers should include exact steps for data capture that comply with EU Medical Device Regulation requirements and the respective authorities.
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Surveys are a valuable tool for conducting PMCF because they can be used to collect data from a large number of patients or users. This data can be used to identify any potential safety or performance issues with the device, and to make sure that the device is still meeting the needs of patients.
The MDR requires manufacturers to conduct PMCF activities that are proportionate to the risk of the device. For low-risk devices, surveys may be the only PMCF activity that is required. For higher-risk devices, surveys may be used in combination with other PMCF activities, such as clinical studies.
Cetas Healthcare has extensive experience helping European medical device manufacturers with high-quality data capture to comply with the MDR Medical Device regulations, among others. Our team of experts can help you design and execute your PMCF Report! Check out our Clinical & Regulatory Services for more information.
In the rapidly evolving landscape of medical devices, ensuring patient safety and product effectiveness is of paramount importance. Post-Market Clinical
The fusion of market research and regulatory considerations can provide valuable insights and help medical device manufacturers make informed decisions