As per EU MDR, for class III and implantable devices (other than custom-made or investigational devices), a manufacturer needs to provide a summary of safety and clinical performance (SSCP). should be written in a way that is clear and easy to understand for patients as well as healthcare professionals.
It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling, the criticality doubles as it becomes necessary to not only be compliant but to even provide the correct instruction for use (IFU).
Recently concluded RAPS- 2019 regulatory convergence at Philadelphia, PA was attended by a good number of representatives from pharma, biotech and device industries, from vendors offering services in various regulatory areas and also by notified bodies.
This being the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for the submission of Type III Drug Master Files (DMFs) in electronic Common Technical Document (eCTD) format. With the deadline extended till May 5, 2020.
All the biopharmaceutical companies must follow respective nation’s laws or regulations in order to develop, manufacture and sale their pharmaceutical products. Before any biopharmaceutical product goes in to market, it has to get marketing authorization from the relevant health authorities.
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 behavior and clinical outcomes.
The European Commission explain the details of how a future system for medical device nomenclature will help to support the EU’s new device and IVD regulations, as well as the Eudamed database, which allows for information to be exchanged between national competent authorities and the Commission.
As EU MDR has already entered into force and will be applicable in May 2020, the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to clinical evidence and post marketing obligations on device companies in proportion with risk class and the type of device.
Post Marketing Clinical Follow (PMCF) is a continuous process to assess and analyze clinical data pertaining to device to verify the clinical safety and performance of the device when used as intended by the manufacturer. Usually device studies are used to acknowledge the information to a manufacturer mainly on the below points:
Regulatory environment has become increasingly complex and making drug labeling a highly regulated and closely monitored activity. As some of you are aware, Health authorities are specific to regulatory requirements for medicinal products on labeling requirements such as patient information leaflets,
Growth of technology brought forth internet enabled Medical Devices which can help with everything from the monitoring of patients to the collection and use of statistical data. This helps to improve medical care across the globe and progresses the medical knowledge of health professionals. The use of these devices provides many financial