How to Obtain European CE Marking for Medical Device

Posted by Charles Wilson on November 30th, 2021

To sell medical devices in the European Union (EU), there must be required to obtain CE Marking or apply CE Marking for a product. CE Marking indicates that medical device complies with the applicable EU regulations and enables the commercialization of products in 32 European countries.

As a legal medical device manufacturer, the responsibility of that device manufacturer for maintaining regulatory compliance and secure CE marking for a product, whether any outsource or all components of manufacturing operation.

CE marking is not a quality mark, but compliance with EU Directives requires meeting specific standards of performance, quality, safety, and efficacy for your product type. There are some logical and procedural steps to getting the CE marking on a medical device. The “old method” required the fulfillment of exceedingly thorough technical conditions. The “new method” comprises more reasonable and uniform requirements for safety and functionality.

Following steps will be helpful as work through it,

(1)Identify medical device status: 

As a medical device manufacturer or importer in the European market, one must identify the class of medical devices required to be marketed. Medical devices are classified according to the associated level of product risk into Class I, II-a, II-b, or III. In-vitro diagnostics devices are distinguished into Class A or Class B.

(2)Identify regulatory requirements and their fulfillment: After the identification of medical device status, a medical device supplier or producer has to identify the requirements of applicable EU directives and fulfill them accordingly.

Some of the main areas where the following requirements concentrate include:

• suitability for the intended application
• medical device safety for the operator and the patient
• the justification that medical device benefits supersede the acceptable risks
• impact of transportation and warehousing of the medical device, and the justification that it does not damage production functionality and safety
• requirements for medical product labeling, instructions for use, and packaging

By demonstrating compliance in these areas, the manufacturer demonstrates that the product is safe and is effective for its intended application. ISO 13485 helps suppliers to gain requirements in these areas.

(3)Development and preservation of the technical files: The topic contains technical documentation of a medical device. It constitutes evidence of every manufacturing stage that determines that the product is compliant.

The CE Marking technical file focuses on some common areas, such as:

• medical device components and material specifications
• medical device product specifications
• validation results of manufacturing processes
• Risk Management Registry of a medical device
• design verification records for medical devices
• design validation reports and clinical evaluation
• labeling specifications
• instructions for use

With the help of CE Marking technical documentation and records, the manufacturer demonstrates not only that the product is compliant with the requirements of the European Directives, but also that all the processes and phases of the manufacturing processes have been documented. ISO 13485 helps to meet the above requirements through the management of medical device files.

(4)Review for product conformity: The supplier or device manufacturer in Europe has to obtain review and approval for certain devices that fall into Class III and all devices in Classes A and B (in-vitro diagnostics devices). Reviewers will evaluate the conformity of the manufacturer’s testing processes.

Before approval, the type of review required for the CE mark is determined by the categorization of the medical device. These review paths involve the assessment of the following:

• Complete Quality Management System review
• Product design verification and validation review
• Self-declaration of conformity
• Review of Quality Management System for manufacturing
• Review of Quality Management System for product
• Review of batch release

The selection of a review path substantially influences the scope and dynamics of the review. That shows the reason why correct medical device classification is very important for suppliers and manufacturers. A QMS based on ISO 13485 is beneficial to meet most of these review routes.

(5)Declaration of conformity: here is the last step in which the supplier of the medical device confirms that the device fulfills all obligations identified in the relevant directives. Moreover, it declares that the device has gone through the program of conformity assessment and is manufactured, designed, and qualified as per the technical files developed. The declaration of conformity is documented on a certificate with all declaration statements of conformity.