1. Summary of certification content

The EU is gradually establishing a unified large market to eliminate trade barriers among its member states, ensuring the free flow of personnel, services, funds, and products (such as medical devices). In the field of medical devices, the European Commission has formulated three EU directives to replace the original recognition system of each member and harmonize the regulations related to the placement of such products on the market.

These three instructions are:

① The Active Implantable Medical Device Directive (AIMD, 90/335/EEC) applies to active implantable medical devices such as cardiac pacemakers and implantable insulin pumps. AIMD came into effect on January 1, 1993. The transition deadline was December 31, 1994, and was enforced from January 1, 1995.

② The In Vivo Diagnostic Device Directive (IVD) is applicable to medical devices for in vivo diagnosis such as blood cell counters and pregnancy detection devices.

③ The Medical Devices Directive (93/42/EEC) has a wide range of applications, including almost all medical devices except for active implantable and in vitro diagnostic devices, such as passive medical devices (dressings, disposable products, contact lenses, blood bags, catheters, etc.); And active medical devices, such as magnetic resonance imaging, ultrasound diagnosis and treatment equipment, infusion pumps, etc. This directive came into effect on January 1, 1995, with a transitional deadline of June 13, 1998 and mandatory implementation from June 14, 1998.

The above directive stipulates that after the official implementation of the directive, only medical device products with the CE mark can be sold in the EU market.

When Chinese medical device manufacturers and export companies sell their products to the EU market, they must comply with the above directives and affix the CE mark, otherwise their products will be difficult to enter the EU market.

2. Classification of medical device CE certification

The classification principles of medical devices are mainly based on their characteristics, such as non-invasive devices, invasive devices, active devices, and other special principles. The definition of classification can be determined based on the MDD guidelines, 93/42/EEC Annex IX, or using the UK Department of Health's disk, and is at the discretion of the manufacturer.

As of January 2000, the directives for implementing the CE mark issued by the European Union are as follows. The applicable products, directive numbers, release dates, implementation dates, etc. are listed separately:

Direct Title

CE Ref. (Main Directive Number)

Entry Into Force (start date and mandatory date)

Active Implantable Medical Device (AIMD) Directive 90/385/EEC 1.1.1993-1.1.1995

Medical Device (MDD) Directive 93/42/EEC 1.1.1995-15.6.1998/4/3

In Vitro Diagnostic Device (IVDD) Directive 98/79/EC 7.6.2000 to 12.7.2003

Considering the degree of danger that the design and manufacturing of medical devices may bring to the human body, medical devices can be divided into the following four categories:

Class I Low risk

Class IIa Low to medium risk

Medium risk in Class IIb

Class III High risk

The classification description is as follows:

Class I low risk, defined as follows:

a. Non invasive devices for transporting, storing, or injecting blood, excluding bodily fluids

b. Non invasive device in contact with injured skin, used to stop exudate c Temporary use of invasive devices for no more than 60 minutes

d. Short term use of invasive devices from oral cavity to throat, ear canal to eardrum for no more than 30 minutes

e. Reusable surgical equipment

f. Invasive devices implanted in teeth for a long time

g. Active devices not classified as Class II

Non sterile medical devices, such as inspection gloves, diagnostic latex gloves, bandages, operating tables, surgical lights, prostheses, wheelchairs, electric scooters, cold and hot compress bags, medical equipment, etc

Medical instruments that require sterilization, such as surgical gloves, knives, OK bandages, etc.

Class IIa is defined as low to medium risk as follows:

a. Non invasive devices for transporting, storing, or injecting blood and body fluids

b. Class IIb (a) directly including filtration, exchange, and heating treatment

c. Class I (d) devices for long-term use

d. Active therapeutic devices for controlling or exchanging energy

e. Active diagnostic device for providing visible light energy for human absorption and displaying the distribution of radioactive agents in the body

f. Disinfecting medical devices

g. Non active device specifically used for recording X-ray diagnostic images

For example: gloves for surgery, various catheters for surgery, blood circuit catheters for kidney washing, aspirators, infusion sets, emergency respiratory equipment, injection needle cartridges with needles, safety needle cartridges, acupuncture and moxibustion needles, scalp needles, ear temperature guns, electronic thermometers, low/medium/high frequency therapeutic devices, infrared electronic toothbrushes, blood circulation machines, disinfection pots, contact lenses, etc.

The risk in Class IIb is defined as follows:

a. Non invasive device for altering blood, other bodily fluids, or injections

b. Non invasive device for subsequent treatment of torn epidermal wounds

c. Long term use of invasive devices that provide energy or produce biological effects through ionizing radiation

d. Except for long-term invasive devices in categories I (f) and III, and active devices with hazardous characteristics (such as electric radiation)

e. Devices for controlling fertility or preventing sexually transmitted diseases

f. All devices used for disinfection, cleaning, and washing of contact lenses

g. Blood bag

For example: blood dialyzer, blood oxygen concentration meter, electric knife device, X-ray machine, ultrasonic spray respiratory therapeutic device, physiological monitor, bone nail, bone plate, artificial joint, condom, blood bag, etc.

Class III high risk, defined as follows:

a. Temporary, short-term, and long-term invasive devices used for diagnosis and monitoring in direct contact with the heart, central circulation, and nervous system

b. Invasive devices that produce biological effects in the body, undergo chemical changes, or control drugs

c. All devices containing medical substances that comply with Directive 65/65/EEC and may have effects on the human body to assist in medical treatment

d. Long term implantable medical devices

e. Devices made from non living animal tissue or its source in contact with injured skin

For example, absorbable surgical sutures, joint injections, brain drainage systems, etc

3. CE certification mark for medical devices

The 'CE' logo originates from the foreign language prefix of the European Community. In English, the prefix of Eurpean Communities is 'EC', which is translated as 'complying with European regulatory requirements'. Due to its French representation as 'Commeunante Europene' with the prefix 'CE', the abbreviation of the European Commission is also 'EC'. Therefore, this symbol is represented as 'CE'. There are two types of CE markings affixed to medical devices. That is, the CE mark without the notified body identification number and the CE mark with the notified body identification number.

If a notified body participates in the conformity evaluation process, it is usually accompanied by a CE mark with its identification number. Due to the need for the notified body to participate in all compliance evaluation procedures except for those in accordance with Appendix VII. Therefore, the CE mark without an identification number is only used for Class I medical devices that do not require sterilization and have no measurement function.

The advantages of the CE logo

According to MDD, if devices bear the CE mark, they can be sold in the market of any member state of the European Union. In EU countries, the old recognition system, which is still in effect, can be used until the transition period (June 13, 1998), but its application is only necessary if the devices placed on the market do not meet MDD requirements (i.e. no CE mark)&127.

The role of the CE mark

CE is a mandatory requirement, and all medical device products sold to the EU market must be labeled with 'CE'. In Europe, in addition to competent authorities such as industry and commerce inspectors checking whether medical devices on the market carry the CE mark, customs will only allow products with the CE mark to pass through the border. In addition, users of medical devices (doctors, hospitals) will also check whether they carry new devices when purchasing them

With CE mark. Obviously, the CE mark can serve as a 'passport' for devices within the EU.

The significance of CE marking on medical devices

The significance of the CE mark mainly includes the following points:

-This device meets the basic requirements of 3MDD

-This device can be legally placed on the market within the European Union.

-The device has passed a corresponding compliance evaluation procedure.

At present, the European Commission has released a list of 19 member states that have converted the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (MIMD) into domestic regulations:

1. Austria; 2. Belgium; 3. Denmark; 4. Finland; 5. France; 6. Germany; 7. Greece; 8. Iceland; 9. Ireland; 10. Italy; 11. Luxembourg; 12 Netherlands; 13. Norway; 14. Portugal; 15. Spain; 16. Switzerland; 17. Sweden; 18. The United Kingdom; 19. Liechtenstein.

4. Preparation and Process for MDD Directive Certification of Medical Device Products

Considering the degree of danger that the design and manufacturing of medical devices may pose to the human body, different types of medical devices have different requirements for obtaining CE mark verification.

The verification process and requirements are as follows:

-Request for verification by the customer

-Assist clients in classifying medical devices and provide validation models and relevant information

-Confirm certified products with customers and prepare quotation data

-The customer confirms that the Technical Construction File (TCF) and quality management system have been fully established.

-The customer confirms and signs the quotation, completing the preliminary contract signing

-Conduct ISO 13485 quality management system validation

-Conduct technical document review

-Complete the audit report and recommend certification

-Issuance of certificates

-Conduct regular reviews annually

Taking the specific product 'gamma knife' as an example to introduce the CE certification process of medical devices

To successfully pass the CE certification of a product, three aspects of work need to be done well. Firstly, collect EU technical regulations and EU (EN) standards related to certified products, and digest, absorb, and incorporate them into enterprise product standards. Secondly, the enterprise strictly organizes production in accordance with the above product standards, which means implementing the requirements of the technical regulations and EN standards into the entire process of product design, development, and production manufacturing. Thirdly, enterprises must establish and maintain a quality system in accordance with ISO9000+ISO13485 standards, and obtain ISO9000+ISO13485 certification.

The EU technical regulations and EN standards that should be followed for gamma knife CE certification. For the 18 categories of industrial product directives currently issued by the EU, from the structure of these directives, they can be divided into vertical directives and horizontal directives. Vertical directives are targeted at specific products, such as medical device directives; The horizontal directive is applicable to various product families, such as the electromagnetic compatibility directive, which applies to all electrical and electronic component products.

For gamma knife, the applicable directives include items 14, 1, and 5, namely the 93/42/EEC Medical Device Directive, 73/23/EEC Low Voltage (LVD) Directive 89/336/EEC Electromagnetic Compatibility (EMC) Directive. The EU standards that support these directives are: (1) EN60601-1 Medical Electrical Equipment Part 1: General Safety Requirements; (2) EN60601-1-1 Medical Electrical Equipment Part 1: General Safety Requirements and First Amendment; (3) EN60601-2-11 Medical Electrical Equipment Part 2: γ  Special requirements for the safety of beam therapy equipment; (4) EN60601-1-2 Medical Electrical Equipment Part 1: General Safety Requirements Section 1.2 Parallel Standard Electromagnetic Compatibility - Requirements and Testing.

The standards (1), (2), and (3) are the basis for Gamma Knife Low Voltage (LVD) testing, while the standards (4) are the basis for Gamma Knife Electromagnetic Compatibility (EMC) testing.

Gamma knife CE certification procedure and content: The European Union divides medical machinery products into four categories, namely: Class I, Class IIa, Class IIb, and Class III. Class I products need to be labeled with the CE mark and can be self declared. That is, the manufacturer prepares technical documentation files for the product, and at the same time tests the product according to relevant EN standards or entrusts a capable laboratory to test and pass the test. If Class IIa, IIb, and III products need to be labeled with the CE mark, they must be verified by a verification agency designated by the European Union. The European Union also stipulates that the prerequisite for obtaining CE certification for these types of products is for the manufacturing plant to be able to obtain ISO9000+ISO13485 quality system certification, obtain ISO9000+ISO13485 quality system certification, and the issuing unit of the certificate should be a certification body recognized by the European Union.

ISO9000+ISO13485 quality system certification and CE certification can be carried out simultaneously, but the CE certificate must be issued after passing the ISO9000+ISO13485 quality system certification. According to the EU classification of products, gamma knives belong to Class IIb, and their CE certification procedures and contents are as follows:

1) The enterprise submits a certification application to the certification agency and fills out a certification inquiry form to submit to the certification agency;

2) The certification agency shall submit a quotation to the enterprise applying for certification, and the enterprise shall sign and confirm to complete the contract;

3) Enterprises shall submit ISO9000+ISO13485 quality system documents, namely quality manuals and procedural documents, to the certification body for system document review; Before the quality system audit, the enterprise should have at least three months of quality system operation records and complete 1-2 internal quality system audits.

4) The certification agency shall issue a certification product testing notice to a laboratory recognized by the certification agency, which will conduct low voltage (LVD) testing and electromagnetic compatibility (EMC) testing on the products applying for certification. If there are any nonconformities during the test, the enterprise shall replace them and retest them until they pass the test. After the test is completed, the laboratory will issue a test report.

5) The enterprise prepares a technical document archive (referred to as TCF file) for applying for certification of products. The above test report is also included as one of the contents of the TCF file. The TCF document is an important document submitted by manufacturers applying for CE certification to the CE certification body, and it is an important basis for the certification body to review and issue certificates. All TCF documents must be prepared in English. The TCF file includes seven aspects of content:

① Introduction: ② Product specification description; ③ The main file content of the design; ④ Risk analysis and assessment; ⑤ Test reports and clinical diagnostic materials; ⑥ Control of document design; ⑦ Declaration of product application.

6) The certification agency conducts a preliminary review of the enterprise's ISO9000+ISO13485 quality system and TCF documents. After the initial review, the certification body will point out the problems in the quality system and TCF documents, and enterprises should improve the quality system and TCF documents accordingly.

7) The certification agency conducts a formal review of the enterprise's ISO9000+ISO13485 quality system and TCF documents.

8) After the formal review is passed, the certification body will sign a framework agreement with the enterprise, clarifying the principles that all parties should follow after obtaining the CE certificate, the scope of product use of the CE mark, and the handling methods for complaints. Then issue ISO9000+ISO13485 quality system certification certificate and CE mark certificate.

Generally speaking, it takes about half a year to a year from the enterprise applying for certification to the certification body issuing the certificate.

Basic requirements of the Medical Device Directive

EU standards are not mandatory as other methods can usually be used to demonstrate compliance with the basic requirements of their directives. However, adopting coordinated standards can bring significant advantages to manufacturers, as long as their products meet the requirements of the corresponding coordinated standards, they are considered to have met the basic requirements. It must be pointed out that the so-called coordinated standards refer to those European standards published in official EU journals.

The main content of MDD basic requirements is summarized as follows:

General requirements:

-Must be safe;

-Must be designed and manufactured according to currently recognized process technology;

-Must achieve expected performance;

-The safety and performance of the product must be guaranteed within the specified lifespan.

-Appropriate transportation and storage requirements must be specified;

-The side effects must be within an acceptable range;

-Chemical, physical, and biological characteristics, such as toxicity and biocompatibility, must be within allowable limits;

-Infection and microbial contamination must be within an acceptable range;

-When working in conjunction with other equipment, it is necessary to consider the impact of environmental conditions (such as EMC).