CE Approval Process for Medical Devices: An Overview
Acquiring a CE mark is compulsory for medical device manufacturers seeking to introduce their medical devices into European markets. The CE mark certification process is rigorous and intricate. Here is a concise overview of the steps involved in obtaining CE approval for medical devices.
Securing CE approval necessitates the preparation of a precise technical file. As consultants specializing in obtaining CE marks for medical devices, we ensure the creation of flawlessly accurate technical files crucial for CE mark approval. The CE mark is an indispensable requirement when marketing your medical device within the EU market.
You can also check our service page for the CE mark for medical devices for more details.
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Step-by-step CE Approval Process for Medical Devices
Securing CE approval for medical devices involves a complex process, but our assistance streamlines the journey for you.
Determining which EU Medical Device Directives Apply to your Devices:
The initial step is determining the EU directive applicable to your medical device. This necessitates following the correct conformity assessment procedure.
Classification of your Device
CE approval hinges on device classification, and assessing associated risks. Devices fall into four categories: Class I, IIA, IIB, and III, each representing differing risk levels based on device characteristics and intended use.
Implementing Quality Management Systems (QMS)
QMS is Quality Management System. CE marking for medical devices requires you to have an appropriate documented QMS. It is suggested that you update your QMS so that it complies with the latest regulations.
Creating a Comprehensive Technical File
Manufacturers seeking medical device CE marking must compile a detailed technical file covering compliance steps, design, composition, functionality, and a clinical evaluation report based on clinical data.
Issuing a Declaration of Conformity (DoC)
Prepare a Declaration of Conformity, that will certify that the manufacturer has the sole responsibility of fulfilling all the directives that are needed for a CE approval for medical devices. To achieve this certificate, you will have to go through the following procedure:
● Identifying the directives for your product (step 1 given above)
● Assess the level of conformity
● Review the technical document
● Affix the CE marking and issue the DoC
● Your product is certified
The Notifying Body Audit
The manufacturer should confirm the classification with a Notified Body, whose role is to determine the level of conformity of the device.
Obtain a CE Marking Certificate
If the Notifying Body audit is successful, you will receive a CE marking certificate, which should be renewed every year.
Applying the CE Mark
Following the above steps enables affixing the medical device CE marking and signing the Declaration of Conformity.
For More Clarity on the CE Approval Process for Medical Devices
Streamlining the CE Approval Process for Medical Devices with Operon Strategist
Obtaining CE approval for medical devices demands meticulous adherence to EU directives. Operon Strategist, a leading EU MDR consultant, specialises in simplifying this intricate process. Contact us for expert guidance in securing CE markings for your medical devices and ensuring compliance, facilitating your market entry into the EU.
