Medical Devices "CE" Technical File: Compliance and Certification Process

Medical Devices "CE" Technical File

CE Certificate

The regulation established by the European Union Commission, which must be complied with by medical device manufacturers; Medical Device CE Certificate. According to the 2017/745 MDR Medical Device Regulation, all safety and performance parameters (chemical, physical, biological, biomechanical, sterility, biological load detection, rapid aging and compliance with other product-specific tests) and strategies for the implementation of these parameters must be determined and as a result, compliance with these features must be proven.

In order for the Medical Device to receive CE marking, all the work done must be brought together as a technical file. The Medical Device Manufacturer demonstrates compliance with the 2017/745 MDR Medical Device Regulation with the Medical Device CE Certificate.

CE certification varies according to the risk group of the medical device. If the product is in the low risk group, the “Declaration of Conformity” prepared under the responsibility of the medical device manufacturer (Declaration of Conformity), it is possible to sell in the market.

However, if medical devices are in the medium and high risk group, they must be inspected and approved by a notified body. 22 descriptive rules are used to help classify a medical device according to risks as Class 1, Class 1 Sterile and measuring, Class 2A, Class 2B and Class 3.

CE Marking and Technical File Requirement

The CE marking indicates that a product complies with certain health, safety and environmental protection requirements in order to be sold on the European Union market. CE marking is only granted for products that comply with the regulations. The Medical Device Regulation (MDR) regulates the manufacturing and marketing of medical devices in the European Union and sets out specific requirements for CE marking.

In order for a medical device to obtain CE marking, it is mandatory to prepare a technical file. The technical file is an important document that shows that the device has passed all the necessary assessments and tests before being placed on the market.

Contents of the CE Technical File

The CE technical dossier contains a large number of documents and data proving the safety, effectiveness and compatibility of a medical device. The preparation of the technical dossier may vary according to the type of device and risk class, but in general the following items should be included:

1. Product Description and General Specifications

• Device Description: Information describing what the medical device is, what function it fulfills and its intended use.
• Model and Serial Number: Device model number, serial number, versions and other identifying information specified by the manufacturer.

2. Design and Production Information

• Design Information: Detailed information about the design process of the device, materials and technologies used.
• Production Process: Production steps, characteristics of the production facility, production control procedures.
• Prototypes and Tests: Creation of prototypes and results of tests.

3. Risk Management

• Risk Assessment: Measures taken to identify, analyze and mitigate the potential risks of the medical device.
• Risk Management Plan: Processes and procedures established by the manufacturer to manage risks.

4. Clinical Evaluation

• Clinical Data: Clinical trials and available data to evaluate the efficacy and safety of the device.
• Clinical Study Reports: The findings of clinical studies, the results of the studies and the effects of the device on human health.

5. Declaration of Conformity

• Declaration of Conformity: An official declaration by the manufacturer stating that the device complies with EU regulations. This declaration indicates that the device meets the requirements and can be applied for CE marking.

6. User and Labeling Information

• User Manual: Detailed instructions on how to use the device.
• Labeling Information: Information on the label that must be included on the packaging of the device (CE marking, manufacturer's name, instructions for use, warnings, etc.).

7. Manufacturer Information

• Manufacturer Name and Contact Information: Full name, address and contact details of the manufacturer of the device.
• Authorized Person: If the manufacturer is outside the EU, an authorized person is appointed and this person checks the technical file.

CE Certificate Obtaining Process

• Determination of Product Class
• Determination of Conformity Assessment Target according to Risk Group
• Establishment of Quality Management System (ISO 13485)
• Creating Technical Documentation
• Audit Process by Notified Body
• Declaration of Conformity (CE)

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