The European Medical Devices Regulation (EUMDR) is a new set of regulations that govern medical devices’ production and distribution in Europe, effective May 26, 2021. The EUMDR requires more stringent clinical evidence for MedTech players than previous guidance (Directive 90/385/EEC, Directive 93/42/EEC). To obtain and renew their Conformitè Europëenne (CE) Mark certifications, many medical device manufacturers will therefore need to collect more evidence proactively via clinical investigations or other real-world data collection activities such as post-market clinical follow-up (PMCF). The key to collecting high-quality data is to rely on excellent guidance and sound technology. 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.

Cetas Healthcare has extensive experience helping European medical device manufacturers with high-quality data capture to comply with EUMDR 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.