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medical Device CE Marking

I3CGLOBAL delivers a US FDA 510k or 510k Certification for Medical Device file that contains enough information about a device to indicate that it is at least as safe and effective as the device it replaces. Visit a website for additional related information.<br>

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medical Device CE Marking

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  1. www.i3cglobal.com MEDICAL DEVICE CE MARKING This Presentation is about what Medical Device CE Marking is and how it can help you market your products

  2. Benefits of Medical Device CE Marking? CE marking medical devices help manufacturers to ensure safety of the device. CE marking medical devices ensure customers will be protected from any defects in the device. CE marking medical devices help companies to increase their sales by showing they have obtained the mark. CE marking medical devices provide several benefits for manufacturers. Medical device CE marking is a European Union requirement. Every piece of medical equipment must mark its conformity with the Medical Device Directive 93/42/EEC. The 'CE' marking indicates that the product complies with all applicable EU directives, standards and regulations.

  3. The Purpose of CE Marking The purpose of CE marking is to provide patients and healthcare professionals in the EU with a visible indication that the product they are using has met the minimum quality and safety requirements set by EU Laws. Medical Device Manufacturer If you are a manufacturer and marketing medical devices in the European Union, you are required to comply with CE marking regulations. CE marking is one of the most important aspects of marketing medical products outside the United States, but many manufacturers fail to fully understand what it entails. Full Range of Medical Products Importance of CE Marking For Medical Devices CE marking is increasingly important across the full range of medical products, including pharmaceuticals, medical devices and equipment, as well as other healthcare-related products such as patient information materials.

  4. Medical Device CE Marking Is A Crucial Part! Medical device CE marking is a crucial part of the process in order to market medical devices within the European region. CE marking is often interpreted slightly differently by each party involved in the process however there are some common ground rules and regulations which apply to the process of CE marking that should be followed at all times. READ MORE

  5. Other Benefits Of CE MARKING CE Marking is a certification that indicates that a medical device has been tested according to the relevant European standards. CE Marking is mandatory for medical devices sold within the European Economic Area (EEA). It is a visible sign of quality that helps gain trust from customers and regulators alike. Higher level of trust in the product, less time spent on certifications and approvals, and more time to focus on developing great products. The Process of obtaining CE marking can be long and complex. It requires manufacturers to submit their products for testing by an independent third party, which then issues a report verifying that the product meets all relevant safety standards.

  6. Importance of CE Marking! Expand your customer base in Europe. 1 Reduce time-to-market by eliminating additional testing requirements; Build trust with customers who have higher safety standards than other parts of the world. It allows you to sell your medical device in any EU member state without having to obtain individual approvals for each country. It signals to customers that your medical device meets all EU regulations and safety standards. It gives you access to the large European market without having to import or export every time you want to sell something there. 2 3 4 5 6

  7. MEDICAL DEVICE CE MARKING Cost associated with CE marking! You can sell your products in almost all EU countries with no additional testing or paperwork. It shows you're committed to meeting high levels of safety and quality standards. It makes it very easier for your new and existing customers to choose your product over others because they know it has been tested and approved by the EU. In addition to the cost of getting certified, there are other costs associated with CE marking, including increased administrative tasks like preparing marketing material and submitting annual reports on production volumes and sales figures for each product line sold in Europe.

  8. Contact Us GET IN TOUCH If you're considering selling your medical devices in Europe, we recommend talking to us about how best to navigate this complex process as soon as possible! ADDRESS WEBSITE EMAIL 75 Executive Drive, Suite 114, Aurora, Illinois – 60504 www.i3cglobal.com enquiry@i3cglobal.com

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