A new feature introduced by the EU MDR is the Unique Identification Number or UDI (similar to the UIN used in the USA). A UDI is a code that identifies a certain product. It is made up of a series of numbers or letters and is made using a standard for identifying and coding devices used all over the world.
ISO 18562, has become the industry standard for testing the biocompatibility of breathing components. It has four parts: general principles, evaluation of particle emission, evaluation of volatile gas emission, and evaluation of liquid bourn leachables in condensate. Clin-r+ provides an in-depth breakdown of these four components of the standard.
The device’s design, intended use claims, composition, and clinical studies are all covered in great depth in the Technical Document. It serves as a device’s “everything you must know” manual, so CLIN-r+ looks at what it entails.
Biocompatibility and how to apply extractables and leachables to medical devices. ISO 10993 now requires knowledge of any chemicals released by a device while it is in use. This is now included in the testing matrix for each device category. Although materials characterisation isn’t the only way to get this information, it’s the most likely way to discover unexpected materials.
Risk management in the medtech industry extends beyond product development and manufacturing to become an integral part of your product’s life cycle. Clin-r+ looks at how ISO 14971:2019 specifies the international requirements for medical device risk management systems, as well as best practices for the device’s entire life cycle.
Labels for medical devices are indispensable. Clin-r+ are here to help you understand labels, the MDR requirements, and how to put them into action on your systems.
What’s the difference between CER, SSCP, and PSUR? Clin-r+ provides a break-down of the aspiration and content of each report, and explains why the reports are required under the EU MDR.
Composing the clinical evaluation report is one of the most difficult tasks when preparing a medical device submission under EU MDR. Clin-r+ has compiled a list of the top five most useful and reliable resources to consult when writing a CER for a medical device.
A Summary of Safety and Clinical Performance (SSCP) is an external document that includes information about a medical device, such as general information about the device, a summary of the clinical data for the device, and possible therapeutic alternatives. Clin-r+ provides information on what is required under EU MDR and how it is used.
What is a PSUR? Periodic safety reporting improves medical devices and the advantages they provide to patients. All devices require either a PMSR or PSUR, and the risk associated with the device class determines which report is required, whether it must be reviewed by a notified body (NB), and the frequency of review.
We provide services globally, so reach out via this contact page and we will reach out to you, within 12 hours to discuss how we can help.
