The CE Mark for medical devices is an essential part of regulations required for bringing the products to European countries. In this article, we will cover everything about the EU CE Mark, starting from what is “CE Mark”, How to obtain the European CE Marking to countries that accept CE Marking for medical devices and more.
What is CE Marking for Medical Devices?
CE marking for medical devices is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). It stands for “Conformité Européenne,” which translates to “European Conformity” in French.
The CE marking demonstrates that a medical device meets the requirements of relevant European Union (EU) directives and regulations, ensuring its safety and performance.
CE marking signifies that the medical device meets all essential safety, efficacy, and quality requirements, allowing it to be marketed and sold throughout the EEA.
It facilitates free movement of goods within the EU market and ensures high levels of protection for patients, healthcare professionals, and consumers.
Steps to obtain European CE Marking for Medical Devices
Although “CE” is not a quality mark, meeting all the EU Medical Devices Regulation (MDR 2017/745) is a must for meeting the standards of quality, safety, efficacy, and performance.
This guide defines the European CE approval process for medical devices.
If your device classifies as a medical device as per the definition of a medical device outlined by MDR below, are the steps to obtain European CE Mark for medical device.
Step 1: Determine the medical device classification in Europe of the device,
Step 2: Implement a Quality Management System (QMS) if applicable to your device. Several companies refer to ISO 13485 to meet all these requirements.
Step 3: Create a CE Marking Technical File or a Design Dossier
Step 4: Compile a Clinical Evaluation Report (CER), following the MEDDEC 2.7/1 rev4 and the MDR guidelines
Step 5: In case if you lack a physical presence in Europe, select and designate a European Authorized Representative (EC REP) who will act on your behlaf within the EU. If you need a representative, you can contact us at Elexes.
Step 6: If you device is not a Class I device or is sterile and lacks a measuring function, the QMS and technical file/design dossier is subject to an audit by a notified body.
Step 7: Get the CE Marking and ISO 13485 certificated from the designated notified body.
Step 8: Prepare a Declaration of Conformity (DoC) that confirms that your device complies with all the regulations outlined in the MDR.
In case you need more information on EU CE Marking or have any question about the same, you can reach out to our experts at connect@elexes.com.
What is the Importance of CE Marking?
No company can sell medical device in EEA countries unless they have obtained CE Mark uless it is exclusively used for research.
In addition, CE Mark brings several opportnities for device across the world as it indicates the device went through risk assessment processes and is safe and high-quality product for the patient.
Key benefits of obtaining EU CE Mark
⦿ Indicates that the device complies with all necessary EU legal requirements
⦿ Several countries outside EEA also accept CE Mark, opening new markets for the device
⦿ Indicates that the medical device is of high-quality and is safe to use
⦿ Allows commercialization in all 30 memeber EEA countries
Elexes' Process of Obtaining CE Marking
Since several steps and documentations are involved in each step of obtaining CE Mark, it is wise to get help of professional CE Mark consultation.
Medical device companies would relate when we say that managing documents can become a problem especially with a paper-based QMS. Even in a hybrid system, the chances of documents to be lost, filled wrongly, etc. is high. Another challenge during CE Mark is storing of physical files.
We have experts who will assist you at every step of the CE Marking process. Our experience will ensure that proper documentation, filing and applications are processed in compliance with all the requirements: Ultimately speeding up the process.
