CE certification of medical devices

Common CE certification standards for medical devices

Standard reference

title

Approval date

Publication No

EN540

Clinical research of medical devices

one thousand nine hundred and ninety-three

C 181 of

1999-06-26

EN550

Sterilization of medical devices - Validation and procedure control of ethylene oxide sterilization

one thousand nine hundred and ninety-four

C 181 of

1999-06-26

EN868-1

Medical devices need sterilization packaging materials and systems

Part I: General requirements and test methods

one thousand nine hundred and ninety-seven

C 181 of

1999-06-26

EN980

A1

Graphical symbols for medical device labels

one thousand nine hundred and ninety-six

one thousand nine hundred and ninety-nine

C 293 of

2000-10-14

EN1041

Information to be provided by medical device manufacturer

one thousand nine hundred and ninety-eight

C 181 of

1999-06-26

EN1441

Information to be provided by medical device manufacturer

one thousand nine hundred and ninety-seven

C 181 of

1999-06-26

EN ISO10993-1

Biological evaluation of medical devices - Part 1: evaluation and testing (ISO 10993-1:1997)

one thousand nine hundred and ninety-seven

C 181 of

1999-06-26

EN ISO10993-4:

two thousand and two

Biological evaluation of medical devices - Part 1: selection of blood sympathetic tests (ISO 10993-4:2002)

C 16 of

2003-01-23

EN13485 :2000

Medical device quality systems - Particular requirements for EN ISO 9001:1994 applications (EN 46001:1996 Revision)

C 32 of

2003-02-11

EN13488 :2000

Medical device quality systems - Particular requirements for EN ISO 9001:1994 applications (EN 46001:1996 Revision)

C 32 of

2003-02-11

EN45502-1

Medical device quality systems - Particular requirements for EN ISO 9002:1994 applications (EN 46002:1996 Revision)

one thousand nine hundred and ninety-seven

C 268 of

1998-08-27

EN46001

Medical device quality system - Particular requirements for EN ISO 9001 applications (EN 46001:1996 Revision)

one thousand nine hundred and ninety-five

C 181 of

1999-06-26

EN46002

Medical device quality system - Particular requirements for EN ISO 9002 applications (EN 46002:1996 Revision)

one thousand nine hundred and ninety-five

C 181 of

1999-06-26

Basic requirements for CE certification of medical devices

Basic requirements are the most important part of MDD, including all the general requirements of medical devices

1、 Basic requirements (General requirements)

1) Safety (any risk compared with the benefits provided by the device must be within the acceptable range, so it is also called risk analysis);

2) Warning (alarm system or warning alarm system) shall be given at least for the preventability or elimination of risks;

3) Performance conformity (basic requirements of products);

4) Device performance and safety validity (the safety and performance of the device must be guaranteed within the service life of the device.) ;

5) Storage and transportation of devices (devices shall not be affected under reasonable transportation and storage conditions).

2、 The specific requirements include the following 14:

1) The design and production of the device must ensure that: the device will not damage the medical environment, the safety of patients, the safety and health of operators or other personnel if it is used in accordance with its predetermined conditions; the potential hazards in use can be accepted by people compared with the benefits of patients, but it should have a high water level protection method.

2) In the design and manufacturing scheme of the producer, it is necessary to consider that the safety rules shall be observed under the existing technological conditions. The producer shall first reduce or even avoid the risks as much as possible. Secondly, appropriate protective measures shall be taken for the unavoidable risks, including the installation of alarm devices. Finally, the weakness of the protective measures provided by the user and the possible risks shall be informed.

3) The device must achieve the function expected by the manufacturer. The design, manufacturing and packaging of the device shall be conducive to the play of various functions specified in Article 1 (a) d.

4) During the service life of the device determined by the manufacturer of the production line, under the pressure that may occur during normal use, the performance referred to in paragraphs 1, 2 and 3 shall be stable and shall not endanger the medical environment, the health of the Harmer, the user or other personnel.

5) The design, production and packaging of the device shall ensure that the performance of the device will not undergo fundamental inversion as long as the relevant regulations are observed during the transportation and storage.

6) The size of side effects can be accepted compared with the performance of the device.

7) Chemical, physical and biological properties.

8) Infection and microbial contamination.

9) Assembly and environmental factors

10) Testing equipment

11) Radiation protection

12) Devices with or connected to other sources of energy

13) Operation information provided by the producer

14) If it is necessary to determine whether the device meets the basic requirements according to the medical data, such as in the case of paragraph 6, the relevant data must be obtained in accordance with appendix X.

Preparation of technical documents for CE certification of medical devices:

"Technical documents" is a very important item in the EU medical device directive. Its purpose is to require enterprises to prepare sufficient technical data and certificates for the competent authorities to spot check or use in case of litigation disputes. The requirements of EU directives for "technical files" are different. Here, I would like to take the requirements of "medical devices" which are most commonly used by Chinese export enterprises as an example to explain.

Example 1: the "technical dossier" required by the medical device directive 93 / 42 / EEC may include the following items:

a. Quality manual and procedure documents of the enterprise

b. Company profile, European agent name and contact information

c. CE compliance statement (or self assurance statement, if the product is used in combination with other equipment, there should be evidence of overall compliance with the basic requirements)

1) Brief description of product name, classification and reference standard terms

2) Product overview (including type and intended use)

a. Technical performance parameters

b. List of accessories, accessories and other equipment used with products

c. Drawings and samples of products

d. Raw materials and suppliers for products

3) Use the product's blending standard / or other standards

4) Conclusion of risk analysis and assessment and preventive measures (en1441 product service hazard analysis report)

5) Production quality control

a. Product data and control documents (including product production process flow chart)

b、