The establishment of European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 posed additional requirements. The significant aspect highlighted was implementing the Post-Market Surveillance system (PMS). Enabling PMS will ensure the devices' safety even after being launched in the market.
In-Vitro diagnostics (IVD) are products that are reagents, instruments, or systems that can detect diseases or other conditions and monitor a person’s overall health to help cure, treat, or prevent diseases.
The classification of an IVD determines the appropriate premarket process for approval. The FDA classifies IVD products into Class I, II, or III based on the associated risk.
|
Classification What, Why, and How of PMSR under EU MDR and EU IVDRBlog Image
The importance of post-market surveillance (PMS) has never been out of the buzz. Regulatory Authorities worldwide have established some stringent rules and regulations to efficiently monitor medical devices even after placing them on the market. Similarly, the European Union (EU) has emphasized PMS in its new regulations. Many requirements have been implied on the manufacturers, one of them being the Post-Market Surveillance Reports (PMSRs). Step- by- Step Process for Obtaining 510(k) Clearance for your Medical DeviceBlog Image
510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent to a legally marketed device (predicate). Devices with moderate risk are required to submit a 510(k) notification, which includes a minority of Class I and III devices and a majority of Class II devices. IVD Self-certification under the EU IVDR and the Elements to ConsiderBlog Image
Class A IVDs under European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/745 require self-certification. The manufacturer is required to self-declare their product’s compliance with the EU IVDR’s requirements and affix the CE marking. While the process for self-declaration seems easy compared to other device routes, the intricates, when ignored, can create complications in placing the device in the EU market. Below are some of the key points that manufacturers need to note while placing Class A devices on the market: Medical Devices – Post-Brexit Regulatory Landscape in the UKBlog Image
With the Brexit commencement, from Jan 1, 2021, there have been a lot of changes in the UK’s medical devices regulations, which the executive Regulatory Authority in the UK – MHRA has devised. Medical device manufacturers willing to enter the UK market especially, England, Scotland and Wales, will have to follow the applicable MHRA UK regulations. While some changes have come into effect immediately, others have a grace period for compliance. What are those changes, and how are they affecting the medical device landscape in the UK? Let’s decode. Classification of Medical Devices and IVDs In Sri LankaBlog Image
Sri Lanka, being majorly driven by imported medical device products, offers a potential market to medical device manufacturers. The medical devices intended to be marketed in Sri Lanka must be registered with the National Medicines Regulatory Authority (NMRA). The registration of medical devices involves a series of activities, including medical device classification into appropriate risk class, obtaining sample import license, manufacturing license, testing of devices in accredited laboratories, and device registration followed by obtaining a commercial import license. Health Canada Releases Notice on Research Use Only COVID-19 TestsBlog Image
Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market. In the event of the ongoing COVID-19 pandemic and to facilitate the supply of essential medical devices and IVDs, Health Canada has released various Interim Orders for the manufacturers, importers and distributors. ANVISA: New Registration Regime for Class II Medical DevicesBlog Image
Brazil’s National Agency of Health Surveillance (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC No. 423/2020). The new resolution declared the elimination of the Cadastro registration pathway for Class II medical devices and IVDs and substituted the same with a notification registration pathway (Notificação). The main goal of this new resolution is to further concentrate on high-risk medical devices and IVDs. Role of MHRA and Post-Brexit Scenario for Medical Devices in the UKBlog Image
Since the commencement of Brexit transition timelines, the entire medical devices community is underway to understand its impact on future trade and Regulatory relations between the European Union (EU) and the United Kingdom (UK). As noted, the UK left the EU on January 31, 2020, as per the Withdrawal Agreement between both the countries. The agreement brings up a transition period until December 31, 2020, which intends to give time for national administrations, businesses and citizens to get ready for the significant changes due to the Brexit. What our Clients say
|
