The CE mark is used in official EU documents. A CE Mark certificate is required to commercialize medical devices in the European Union. This certification verifies that a device satisfies all medical device regulatory requirements under the new Medical Devices Regulation (MDR 2017/745). The CE mark on a medical device or IVD certifies that the device meets the regulatory requirements for entry into the EU market. A minor error in a technical file may cause your device's CE certification to be delayed. As a professional CE certification consultant, Thomas Regulatory Resolution can increase your chances of obtaining CE Marking certification without difficulty.

Why do you need CE Mark approval for medical devices?

CE certification is required to place a medical device on the EU market. To sell products in the European Union and build trust, manufacturers must follow the guidelines and requirements provided by the regulatory body. Medical device manufacturers are responsible for maintaining regulatory compliance and obtaining CE marking on their products. The CE marking on a medical device or in vitro diagnostic device indicates that the device meets the legal requirements for the sale of medical devices on the EU market.

Your Perfect EU CE Mark MDR Medical Device Consultants Are Here!
EU CE Mark MDR Medical Device Consultant

Procedure for registration for import of medical Devices

To obtain the CE marking on a medical device, the manufacturer must document the product's quality, safety, and performance. As a medical device consultant for CE marking, Thomas Regulatory Resolutions will help medical device manufacturers to market their medical devices in the EU market (European market). Our EU CE Mark MDR Medical Device Consultant experts delve into your device design, risk analysis, biosafety, clinical evaluation, test reporting, and post-market surveillance. The CE marking on a product indicates that the product necessarily meets the minimum legal requirements of the relevant directives allowing the product to be legally placed on the market in any Member State in Europe.

Why choose Thomas Regulatory Resolutions for EU CE certification for your medical devices?

The CE marking approval process varies depending on the type of medical device, following the MDR. CE marking approval includes some additional factors like product quality, technical filing to ON, clinical evaluation, etc. Many medical device manufacturers don't read the EU MDR regulations and get stuck somewhere in the process, which can delay the project so you don't need to know where to start and who is a suitable consultant in CE marking for you. Thomas Regulatory Resolutions don't abandon you, we make sure our clients are CE-approved with minimal effort to facilitate your approval process.

Conclusion

Thomas Regulatory Resolutions medical device consulting company provides end-to-end solutions and provides cost-effective services. We work hard for customer satisfaction because customer satisfaction is the key to our success. We also provide FDA Establishment Registration Medical Device Listing Consultants service in Latin America, Asia, Eastern Europe, & Middle East.

Foreign establishments that import or request to import into the United States must identify a US FDA agent during the registration process. The US FDA agent must be located in the US and will act as the primary and/or default contact point between FDA and the company. At Thomas Regulatory Resolutions, you can also get the perfect FDA US Agent Consultant services.