NEW MEDICAL DEVICE REGULATION
INTERVIEW WITH CRISTINA HUGUET, REGULATORY RESPONSIBLE
The purpose of any medical device is to make significant improvements to a patient’s quality of life, beyond pre-market findings, that demonstrate continued safe, effective use. This evidence should support any and all claims and indications regarding the device and for that reason post market follow up studies as a part of port market surveillance program are essential to help manufacturer and medical practitioners in this complicated task. The requirements of the new Medical Device Regulation and the definitions of clinical evaluation and clinical evidence are explained
What is the medical device regulation?
The Medical Device Regulation (MDR) is new rules for medical device circulation, was officially came into force in 2017, for existing medical devices new rules will be effective from May 26th, 2020.
The most significant changes in the regulation include product scope expansion; implementation of unique device identification; specifications; and reclassification of devices according to risk and etc. Furthermore, rigorous post-market oversight, more accurate clinical evidence for class III and implantable medical devices as well as systematic clinical evaluation will be requested.
Why clinical evaluation of class II and class III medical devices is so important?
Clinical investigations should be conducted obligatory from now on. Post-market clinical data as part of the ongoing assessment of potential safety risks should also be collected and retain by investigator and requested support from every local markets where medical device circulated.
What means clinical evidence for medical devices?
Clinical evaluation is conducted throughout the life cycle of a medical device, as an ongoing process. Clinical evaluation is mandatory for initial CE-marking and it must be actively updated thereafter. There should be an adequate rationale if a clinical trial is deemed unnecessary.
What is Post Market Surveillaince?
The post market surveillance (PMS) is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behaviour and clinical outcomes.
PMS regularly generates new data, e.g. safety reports, results from published literature, registries, trends reports, post market follow up (PMCF) studies, and other data about device usage. The risk profile of the device evolves from these efforts and can be used to effectively develop the PMS strategy for the device. It is important to note that the requirements for PMS should be directly proportional to the risk associated with the device based on its intended use. Those data need to be evaluated for information that has a potential to change the evaluation of the risk/benefit profile, and the clinical performance and clinical safety of the device.
What is Post Market Clinical Follow up (PMCF)?
PMCF may be warranted to ensure adequate characterization of the real-world clinical use of the device. In order to determine needs for PMCF, residual risks and any uncertainties or unanswered questions should be described. Aspects such as rare complications, uncertainties regarding medium- and long-term performance, or safety under wide-spread use should be also carefully examined. PMCF studies may include extended patient follow-up times for pre-market studies, new clinical investigations, or a review of relevant retrospective data from patients previously exposed to the device.
CONCLUSION
The purpose of any medical device is to make significant improvements to a patient’s quality of life, beyond pre-market findings, that demonstrate continued safe, effective use. This evidence should support any and all claims and indications regarding the device and for that reason PMS and PMCFs are essencial to help manufacturers in this complicate task.
POSSIBILITY TO SHARE THE EXPERIENCE AND WORK RESULTS WITH OTHER PROFESSIONALS IN COMMUNITY CONTRIBUTE TO ESTABLISH MAXIMUM SAFETY FOR MEDICAL DEVICE AND THEIR USERS.
Please participate in Post Market Clinical Follow Up through our new interactive platform developed in compliance with new Medical Device Regulation (MDR)