CE MARKING FOR IVD MEDICAL DEVICES – In Vitro Diagnostic Devices
At Ascent EMIRATES, we are proud to be a leading provider of CE Marking For IVD Medical Devices. Our team of experts can help you make sure that your medical devices are compliant with all requirements of the European Union’s Medical Device Directive and carry the CE Mark, making it easier to sell in EU countries.
CE Marking Requirements For IVD Medical Devices:
Ce-IVD Certification is a requirement for medical devices that are sold in the European Union. This requirement serves as a sign that the device is compliant with all EU safety, health, and environmental protection regulations. If you are an IVD manufacturer, you need to make sure that your products adhere to the CE Marking requirements before selling them in the EU.
CE marking also demonstrates that your IVD has been manufactured following applicable EU legislation and is necessary for you to legally sell your product in the EU. By CE marking your products, you are taking the necessary steps to ensure that they are safe and work as intended.
Do not forget that you must affix the CE marking at the time of manufacture, and it must be visible and legible. With CE marking, you can have peace of mind knowing that your product is compliant with all EU regulations and ready to be sold in the EU! Placing the CE marking on your product and its associated documents shows that your product is compliant.
The CE marking is valid across the entire EU and is a sign of quality and safety. No matter where your product is manufactured, you can rest assured that it meets the applicable EU requirements for safety and performance. If you have any questions regarding the CE marking process, we are here to help and provide you with the support you need.
If a manufacturer has applied for the CE Marking for IVD Medical Devices Requirements but has yet to receive it, they can still affix the marking “CE” followed by the words “notified body’s documentation number” and the date of the first introduction on the market. This is known as “CE pending” and allows the manufacturer to sell their product while they await the decision of their application.
How Our Notified Bodies Ensure Your Compliance With New Regulations For CE Marking For IVD Medical Devices?
With the new CE-IVD Regulations for CE Marking For IVD Medical Devices coming into effect in May 2022, it is essential to make sure that your medical device products are compliant. However, this can be a daunting task. Fortunately, our certified notified bodies (NBs) are here to help you meet all the necessary certification requirements.
Ascent EMIRATES is an independent third-party organization and we have been authorized by the European Commission to assess and certify the conformity of medical devices following the requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR).
Our notified bodies assure that your product meets all the applicable requirements and performs according to its intended purpose. After the evaluation process, we will provide you with a CE Marking For IVD Medical Devices, which is proof that your product is compliant with the latest standards and regulations.
We are dedicated to helping you design, manufacture, and sell IVD products without any faults or risks. We help to ensure that your products are safe, effective, and of high quality, so you can meet the requirements of Directive 2014/53/EU and IVDR CE Marking, and be sold throughout the European Union.
Ascent EMIRATES is the perfect choice for ensuring that your product is compliant with the latest IVD Medical Device regulations and allowing you to reach your customers in the EU. We guarantee that we will provide the best service without compromising on quality, giving you the peace of mind that your medical devices will be compliant with IVD Ce Mark.
Our notified bodies provide the certifications that are required for CE Marking for In Vitro Diagnostic Medical Devices, so you can be sure that your products are of the highest quality and comply with the latest regulations. If we find any issues with your IVD products, we will provide you with actionable advice on how to improve safety and quality.