1F,Bldg.H, Hongfa Science and Technology park, Tangtou, Shiyan, Bao’an District, Shenzhen,China.
1F,Bldg.H, Hongfa Science and Technology park, Tangtou, Shiyan, Bao’an District, Shenzhen,China.
Medical equipment CE certification (MDD) overview
The EU Member States to eliminate the trade barriers, and gradually establish a unified big market, to ensure that personnel, services, capital and products (such as medical devices). The free circulation in the field of medical devices, the European Commission formulated the three EU directive, to replace the original approval system to make members. Relevant provisions of this kind of products on the market coordinated.
These three instructions are:
1. Active Implantable Medical Devices Directive (AIMD, 90 / 335 / EEC), suitable for pacemakers, insulin pumps and other active implantable medical devices implanted.AIMD can come into force on January 1, 1993. The transition deadline is December 31, 1994, from January 1, 1995 to enforce.
2. in vitro diagnostic device directive (IVD), suitable for blood cell counter, diagnostic medical devices pregnancy detection devices in vitro. The instruction is still in the drafting stage, probably in late 1998 or early 1999 formally implemented.
3. (Medical Devices Direc-tive medical devices, 93 / 42 / EEC), the scope is very wide, including almost all of the medical devices in addition to active implantable and in vitro diagnostic medical devices, medical devices (such as passive dressings, disposable products, contact lenses, blood bags, catheter etc.); and active medical treatment equipment, such as nuclear magnetic resonance instrument, ultrasonic diagnosis and treatment, infusion pump.
Medical equipment CE certification (MDD) core requirements:
One of the basic requirements (General requirements)
(a) any safety risk and equipment to provide benefits in comparison, must be within the acceptable range, it is also known as risk analysis);
B) the risk of preventable or eliminated, at least should be given a warning (alarm system or warning alarm system);
C) performance compliance (the basic requirements of the product);
D) equipment performance and safety of validity (safety and performance of the equipment must be guaranteed. In the life of the equipment inside);
E) storage and transportation equipment (should ensure equipment in reasonable transport, storage conditions are not affected).
Two, the basic requirements include the following 14:
1. devices must be designed and manufactured according to the predetermined conditions: the use and safety devices, patients will not damage the medical environment, operators or other personnel safety and health; and patients with potential risk when using benefit comparison can be accepted, but should have a high level of protection measures.
Design and manufacture of 2. producers, must comply with the safety standards in the condition of considering the existing technology, the producer shall:
First: we should reduce or even avoid risk as much as possible
Secondly, take appropriate protective measures of risk can not be avoided, including the installation of alarm device;
Finally, inform the user provided protection measures of weakness and risk may bring.
3. instruments must be made to expect producers function. Equipment design and manufacturing and packaging should be conducive to the first (2) (A) D functions more provisions of the play.
4. in the production line to determine the equipment life period, in the normal use of the possible pressure, the performance of the section 1,2,3 should remain stable, do not harm the medical environment, harm patients, users and other persons health.
5. design of equipment, production and packaging shall ensure that the performance of equipment during transport and storage as long as comply with the relevant provisions of fundamental inverter does not occur.
The use of the performance of 6. side effects compared with the size of the device can be accepted by people.
7. chemical, physical and biological properties
8. infection and microbial contamination.
9. assembly and environmental factors
10. detection equipment
11. radiation protection
12. with energy or other energy and connected devices
13. operation information producers
14. if you need to determine whether the data according to the medical equipment to meet the basic requirements, such as the sixth paragraph, the relevant data must be obtained in accordance with the provisions of appendix.
Medical equipment CE certification (MDD) product classification
The medical device directive in Appendix nine in 18 rules, according to the degree of risk of medical products, the product will be divided into class I, II A, II class B, class III.
Product classification rules:
1, the rules applied by instruments intended use decision;
2, if the instrument is fit and other instruments, classification rules were applied to each apparatus;
3, accessories can be used in conjunction with other instruments classified separately;
4, start or affect the software and equipment some devices belonging to the same type.
Time: time (<60 minutes), short term (<30 days), long-term (>30 days)
Non traumatic injury, through aperture trauma, surgical trauma, implantation.
Application location: central circulation, the rest of the central nervous system.
Energy supply: passive and active.
Rule 1 - 4, all non traumatic devices are in class I, unless they:
For the storage of body fluids (blood bag exception) - II
In the Ila class or higher type of active medical device class II
Change the II A / II B fluid composition class
Some II A / II B wound dressing class
Rule 5, medical devices into the human body size
Temporary use (compression dental materials, examination gloves) I
The short-term use (catheter, contact lenses) - II
The long-term use of II B (normal dental floss)
Rule 6-8, surgery instruments
Then use the surgical instruments (pliers, axe) I
Temporary or short-term use (needle surgical gloves) - 11
Long term use (pseudarthrosis, intraocular lens) II B
With the central circulatory system (CCS) device III or central nervous system contact
Rule 13, combined with the medical material equipment (pulp material containing spermicidal condoms, containing antibiotics) III
Rule 14, contraceptives (condoms, uterine cap II B (II) b/III type intrauterine device class III)
Rule 15, cleaning or sterilizing equipment
Medical devices (endoscope disinfection) - II
Contact lens (disinfectant, nursing liquid) - II
Rule 16, for recording X X-ray image device (X - ray) - II
Rule 17, using animal tissue apparatus (bio) heart valve, gut, collagen type III)
Rule 18, blood bag II B
Rule 9, give or exchange energy treatment equipment - II
(muscle stimulator, electric drill, skin phototherapy machine, hearing aid) a potential danger mode II B
(infant incubator, high-frequency electric knife, ultrasonic lithotripsy machine, X machine)
Rule 10, diagnostic instruments
Energy (nuclear magnetic resonance, ultrasonic diagnostic instrument) - II
Diagnosis / II a drug distribution in vivo radiation monitoring
(r camera, positron emission imaging)
Diagnosis / monitor physiological function (ECG, EEG) - II
A dangerous situation monitoring the physiological function of II class B
(blood gas analyzer in operation)
Emit ionizing radiation (X ray diagnosis on II b)
Rule 11 control drugs or other substances out of the human body active device class II
(suction equipment, supply pump)
Such as working in a potentially dangerous II class B
(anesthesia machine, ventilator, dialysis machine, hyperbaric oxygen)
Rule 12. all other active medical device belonging to the class I
(observation lamp, dental chairs, wheelchairs, dental treatment lights, recording active devices for image processing on diagnosis)
Medical equipment CE certification (MDD) technical documentation (TCF) requirements
Technical documentation "is a very important matter in the medical device directive, it is the purpose of technical documentation and certification requirements prepared for the enterprise, the competent authority checks, or litigation disputes.
The medical device directive MDD 93/42/EEC "technical files may contain the following items:
The quality manual and procedures of A. Enterprises
B. profile in Europe and the name of the authorized representative, contact
C.CE declaration of conformity (or self assurance statement, if the product is combined with other equipment and materials, that should meet the basic requirements of the whole)
1. the name of the product, a brief description of the classification and reference standard terms
2. product overview (including the type and intended use)
A) history of the product
B) technical parameters
C) products with the use of accessories, fittings and other equipment list
D) product icons and samples
E) by the supplier of raw materials and products
3. use the product of the harmonized standards and / or other standard
Analysis of the assessment result and the 4. risk prevention measures (ISO14971 service risk analysis report)
5. the production quality control
A) product information and documents (including production flow chart)
B) sterilization method and confirm the product description
C) sterilization validation
D) quality control measures
E) product stability and the validity of the description
6. packaging and labeling
A) packaging materials
7. technical evaluation
A) product inspection reports and relevant documents
B technology overview and authoritative view)
8. potential risk assessment
A) product potential risk test report and related documents
B) overview of potential risks and authoritative view
9. clinical evaluation
A) product clinical test report and related documents
B) clinical overview and authoritative view
1. clinical studies (including physical properties, biochemistry, pharmacology, pharmacokinetics and toxicity, efficacy testing, sterilization certificates, drug compatibility etc.)
2. biological compatibility test (A) EN30993 the first part: cytotoxicity, photosensitive, intradermal stimulation reaction, acute systemic toxicity, pyrogenicity, subacute toxicity, genetic toxicity, implantation of hemolysis; B) support test: chronic poisoning, carcinogenicity, regeneration / growth of biological toxins, cause degradation.)
3. clinical data (clinical study or description of clinical research)
4. packing certificate (EN868)
5. labels, instructions for use (EN980, EN1041)
6. conclusion (accepted design files corresponding to interest risk statement)
The file must be in one of the EU's official language (English, German, French), but the instructions must use user's language. All documents should be written in the last shipment after at least five years.