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EC Machine Directive
Machine safety inspection &risk assessment
Electrical safety inspection EN60204-1
UL 508 STD
ISO 9001 Quality System
ISO 14001 certification
ISO 13485 certificate quality of medical devices
CE Medical Devices Directive

How to Get Medical Devices CE certification

Europe has three associated with medical devices directive, namely active implantable medical devices (referred AIMD) Directive 90/385/EEC, Medical Devices Directive (referred MDD) 93/42/EEC, in vitro diagnostic medical devices (referred to IVDD) Directive 98/79/EC. EU's various medical devices directive, including medical equipment classification rules, product certification course, on the quality system and technical file requirements.

  • Medical Devices Directive Category

Manufacturers need to do depending on the product use product classifications, the patient or the user's risk medical devices and conformity assessment programs can therefore be determined. The higher the risk, the conformity assessment program also more stringent.

  • Active Implantable Medical Devices (AIMD90/385/EEC)

Any surgical or medical methods through all or part of the implanted or inserted and set to remain in the body's natural pores of the active medical devices.

  • Medical Devices Directives (MDD93/42/EEC)

   Designed by the manufacturer for use in the human body alone or in
combination with any apparatus, equipment, fixtures, materials
     Or other items, including the necessary software, want to achieve the
following situations:
• diagnosis, prevention, tracking, treatment to reduce disease
• diagnosis, tracking, treatment or dressing the wound or disability site
• anatomy or of a physiological process of investigation, replacement or repair
• Contraception   

And these devices should not have pharmacological, immunological or metabolic action, but can have a supplementary.

  • In Vitro Diagnostic Devices (IVDD98/79/EC)

Any manufacturer designed reagents used alone or in combination, reagent product, calibrator, control material, kit, instrument, apparatus, device, or system whose purpose or predominantly provided only been the subject, including blood and tissue, the body derivatives, in vitro test information such as:
- Physiological or pathological state
- Congenital anomalies - patient safety and compatibility receptor
- Measures to track treatment

Specimen containers, whether in the form of a vacuum, especially as for installing from the human body specimens in vitro diagnostic test For the purpose, shall be considered as in vitro diagnostic medical devices.
Products to be passed CE certification, need to do work in three areas.

  •  First, the collection and certification of products related to EU technical regulations and European (EN) standards, through digestion, absorption, into the enterprise product standards.
  •  Second, enterprises in strict accordance with the above product standards organization of production, that is, the above-mentioned technical regulations and EN standards, implement enterprise product design and development and manufacturing of the entire process.
  •  Third, companies must follow the ISO9001 + ISO13485 standard construction and maintenance of the quality system and obtained ISO9001 + ISO13485 certification.

EU to medical device products into four categories, namely: first class Ⅰ, Ⅱ a first class, first class Ⅱ b, Ⅲ class. Type Ⅰ products to affix the CE mark can be taken to declare their own way. Namely the preparation of the technical file vendor files, while self-relevant EN standards for product testing or commissioned by competent qualified laboratory for testing. Section Ⅱ a class, first class Ⅱ b, Ⅲ products to affix the CE mark, it must be verified by the EU institutions designated authentication.

The EU also provides that these products have received CE certification is a prerequisite for the manufacturer to be able to live ISO9001 + ISO13485 quality system certification, ISO9001 + ISO13485 quality system certification, and the units should be awarded a certificate for the EU accredited certification bodies. ISO9001 + ISO13485 quality system certification and CE certification can be performed simultaneously, but CE certificate must be verified only after ISO9001 + ISO13485 quality system certification passed.

Classification of the product in accordance with the EU, its CE certification programs and reads as follows:
1) enterprise application for certification to the certification bodies, and fill out a single cross certification body certification inquiry;
2) The certification body corporate to apply for certification made ​​quotation, corporate signature confirmation to complete the contract;
3) submit to the certification body corporate ISO9001 + ISO13485 quality system files and program files that the quality manual for certification bodies audit file system; quality system audit before, companies should have at least three months quality system operating records and complete 1 - 2 internal quality system audit.
4) certified product testing certification bodies issuing notice to the certification body accredited laboratory, the laboratory will have to apply for certification of products for low voltage (LVD) and Electromagnetic Compatibility Testing (EMC) testing. If you fail to meet the test by the enterprises to change after the next re-test until tested so far. End of the test, the laboratory test report issued.
5) prepare certified enterprise product technical file archives (referred to TCF file). The test report also serves as TCF file contents. TCF file is a manufacturer applying for CE certification CE certification agencies to submit an important document, which is an important certification bodies audit certification basis. TCF file must all be prepared in English.
TCF file includes seven aspects:
① Introduction:
② product specifications narrative;
③ The main design file contents;
④ risk analysis and assessment;
⑤ test reports and clinical diagnostic data;
⑥ design information control;
⑦ Declaration of product applications

6) The certification body of the enterprise ISO9001 + ISO13485 quality system and TCF file first instance. After preliminary examination will indicate the quality system certification bodies and TCF file problems, enterprises should accordingly improve the quality system and TCF file.
7) The certification body of the enterprise ISO9001 + ISO13485 quality system and TCF file a formal audit.
8) after the adoption of a formal audit, certification bodies and enterprises signed a framework agreement, the parties expressly obtained CE certificate products should follow the principles and scope of the CE mark.
Then awarded ISO9001 + ISO13485 quality system certification and CE mark certificate.
Generally speaking, from the enterprise to the certification body for certification certificate takes about six months to one year.

  • CE mark validity

Products obtained CE certification, you can post on the CE mark, but only submitted when applying for certification as described in TCF products, affix the CE marking means that the product can enter the EU market and the products obtained CE certification requirements to enter the area countries and regions. CE certification is valid for five years.


Declaration of conformity templates (medical devices).docx downloads>
The IVDD 98_79_EC Directive.docx downloads>
The Medical Devices Directive 93_42_EEC.docx downloads>

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