Demonstration of Equivalence The MDR (Annex XIV, Part A) emphasizes the importance of considering technical, biological, and clinical characteristics when demonstrating equivalence to other devices. The demonstration of equivalence must adhere to the requirements outlined in Part A, section 3 of Annex XIV of EU MDR. Annex XIV part A requires that the manufacturer should…
How to Write a Medical Device Clinical Evaluation Report Under MDR 2017/745 One of the most important documents that a medical device manufacturer has to produce under EU MDR 2017/745 is a Clinical Evaluation Report (CER). It provides proof that a device does what it is intended to do, is safe for patients and users…
Class I medical devices under the EU MDR are considered low-risk devices. These medical devices are usually non-invasive and for transient use, such as hospital beds or bandages, or invasive tools used only transiently in body orifices, such as dental impression materials. Class I devices can be active, such as examination lamps. However, the MDCG 2021–24 Guidance…
Learn why toys need CE mark and what role it plays in making toys safe for use in Europe. Discover why CE marking is necessary for toys and how NOVAREG can help with this task. Ensuring Safety: Do Toys Need a CE Mark? In the EU, the safety of people is paramount particularly for products…
Find out the role of caffeine and the regulation by the FDA concerning labelling in the enhancement of consumer information. We need to know how beneficial labeling is in the enhancement of a customer’s decision to act as well as the promotion of public health. Why Caffeine Labelling Is a Hot Topic Caffeine having a…
At present, the healthcare industry in Saudi Arabia is quickly developing. While the global demand for reliable medical supplies grows significantly, it is critical to establish the medical devices’ safety and effectiveness. This is where ISO 13485 certification in Saudi Arabia can come into the picture and offer a standard model for the organizations that…
NOVAREG helps medical device manufacturers bring their products to market confidently and quickly by helping them obtain FDA 510k clearance. Best 510k Consultants, London, UK Whether you are a start-up company taking your first Class II device to market or an established manufacturer looking to enter the US market, our professional 510k consultants are here…
A premarket submission made to the FDA demonstrating that the device is at least as safe and effective, Substantially Equivalent (SE), as a legally marketed device that is not subject to PMA. It is a key pathway that any medical device manufacturer planning to market in the U.S. must understand. Predicate Device Predicate devices are…
A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose. Any medical device approved by the FDA Center for Devices and Radiological Health is classified…
As a means of entering the U.S. market, companies producing medical devices, medications, and related products must follow steps set by the U.S. Food and Drug Administration (FDA). This process involves multiple steps, with one crucial step being the FDA 510k Q Submission. During this step, the FDA provides companies with answers regarding specific regulation areas, requirements,…