The MDCG has released a revised document, MDCG 2022-4 Rev 2, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD. This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3e) MDR.
Under the MDR 2017/745, medical devices are classified into different classes based on their intended use and potential risks to patients. The MDR also includes additional requirements for certain devices, including borderline products.Borderline products are those that have characteristics of both medical devices and other products such as:– Borderline between medical devices and medicinal products,– Borderline between medical devices and substances of human origin– Borderline between medical devices and cosmetic products– Borderline between medical devices and personal protective equipment It’s important to understand the mode of action of the product to truly determine the regulatory framework. Incorrectly classifying a product can result in huge financial loss. In the case of borderline products, careful assessment[…]
Choosing the right Notified Body for certifying your medical device is important. Factors such as costs, Notified Body review times should be considered when making this decision. We work with many Notified Bodies across different device groups.
The FDA Breakthrough Devices Program speeds up medical device development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
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CMS can help you with your internal audit. Contact us to book your next internal audit. We are also hosting a three-day Auditor training session on May 14-16 2024. Contact us to book your spot.
As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach. About CMS: CMS is a service provider for the following: Therapeutic Goods: Cosmetics: Miscellaneous: George Loizou |[…]
