How to Use ISO 13485 Standard For CE Marking Approval of Medical Devices?

Getting the CE marking on your device involves some logical and formal procedures. The “old technique” demanded that incredibly stringent technical requirements be met. The following steps will be useful as you move through the “new way,” which includes more fair and standard requirements for safety and functionality: 

•  Identify medical device status: 

As a medical device maker or importer on the European market, you must decide the type of medical device to market. Class I, IIa, IIb, and III medical devices are classified according to the level of product risk they pose. Devices for in vitro diagnosis are classified as Class A or B.

• Recognize regulatory requirements and their fulfillment: 

1. After assessing the status of a medical device, the provider or manufacturer must identify and comply with the requirements of the applicable EU directives. These standards center on several crucial areas, including:
2.  Medical equipment safety for the user
3. The explanation is that medical device advantages exceed the allowable risks.
4. The impact of medical device transportation and warehousing and the argument that it doesn’t affect production functioning and safety.
5. appropriateness for the intended application or purpose
6. standards for medical product labeling, directions for usage, and packaging
7. The maker demonstrates compliance in these areas to prove that the product is safe and appropriate for its intended usage. Suppliers can meet these requirements using ISO 13485. 

• Development and preservation of the technical files: 

This is sometimes referred to as a medical device’s technical documentation. It comprises paperwork from each stage of production demonstrating the product’s compliance. The technical files focus on a few common themes, such as:

1. Medical device components and material standards
2. medical device product specs
3. validation results for manufacturing processes
4. Risk Management Registry for a Medical Device
5. design verification records for medical devices.
6. Design validation report and clinical evaluation.
7. Labeling Specifications
8. instructions for use 

The maker demonstrates not only that the product meets the European Directives’ criteria through the use of technical paperwork and records, but also that all manufacturing processes and stages have been recorded. The management of medical device files under the ISO 13485 standard allows it to meet the aforementioned standards.               

• Review for product conformity: 

Suppliers and manufacturers in Europe must obtain evaluation and approval for Class III (Active Implantable Medical Devices) and Classes A and B (In vitro Diagnostics Devices). Reviewers will examine the compliance of the manufacturer’s testing processes.

The medical device’s classification determines the type of assessment required prior to CE mark approval. These review paths include an assessment of the following:

1. Complete the Quality Management System review.
2. Review of product design verification and validation.
3. Self-declared conformance
4. Review of Quality Management System for Manufacturing
5. Review of the Quality Management System for the product
6. Review the batch release  

The choice of path has a considerable impact on the scope and dynamics of the review. For suppliers and manufacturers, the proper classification of medical devices is critical. The bulk of these review routes can be addressed by implementing an ISO 13485-compliant quality management system. 

• Declaration of conformity:  

The medical device’s provider validates one final time that it meets all of the requirements mentioned in the relevant directives. It also specifies that the item has completed a conformity evaluation method and is made, developed, and qualified in compliance with the technical files generated. The declaration of conformity on a certificate includes all declaration statements of conformance.