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CE IVDR Certification

After 1999, all medical devices exported to Europe are required to have CE Mark attached. Therefore, it is essential for domestic medical device manufacturers to acquire CE Mark for export to Europe. We provide many CE IVDD / IVDR technical advice to domestic medical device manufacturers.

CE IVDD / IVDR must satisfy EU requirements for products through clinical and analytical performance tests and stability tests, and also conduct certification audits for quality management systems through production system verification (ISO13485: 2016 certification). Because it is set as a necessary condition, it takes longer than CE Mark for general products. In order to acquire CE Mark, the quality system stipulated by the ISO13485 standard must be established and operated. After May 26, 2022 in the existing IVDD (Directive 98/79/EC for in vitro diagnostic Medical devices) In Vitro Diagnostic Medical Devices Directive, IVDR (Regulation (EU) 2017/746) In Vitro Diagnostic Medical Devices Act Accordingly, a customized transition period will be introduced and implemented.

• Types of CE marking and countries to which it is applied

  • 1) CoC: In case of Class B or higher, the system certificate and CE mark certificate are issued by the relevant certification body after the certification body audit.
  • 2) DoC: Self-declaration is stipulated in Article 48 and Annex IV (EU DOC) and Annex V (CE Marking). Therefore, after completing the writing of the technical document, the name, address, written classification rule, product name, relevant certification body, date, and representative You can attach the CE mark by writing your own document with the signature of At this time, you must designate a European agent with an address in Europe and report it to the European Food and Drug Administration.
  • 3) Applicable country
    - EU (European Union): Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, the Netherlands
    - EFTA (European Free Trade Association): Switzerland, Liechtenstein, Norway, Iceland
    - EU Associate Countries: Bulgaria, Croatia, Romania, Turkey
    • Classification of in vitro diagnostic medical devices for CE/IVDR certification
    Classification system: Class D, Class C, Class B, Class A
    Based on the potential risk, it is classified into 4 grades.
  • 4) Time to apply CE IVDR
    • Apply IVDR from May 26, 2022
    - Class A (non-sterile equipment)
    - Medical devices to be newly registered after May 26, 2022
    • Apply IVDR from May 26, 2025
    - Medical device evaluated by Notified Body under IVDD (Directive 98/79/EC)
    - IVDR Class D medical devices (However, medical devices declared conformity under IVDD (Directive 98/79/EC) before May 26, 2022)
    • Apply IVDR from May 26, 2026
    - IVDR Class C medical devices (However, medical devices declared conformity under IVDD (Directive 98/79/EC) before May 26, 2022)
    • Apply IVDR from May 26, 2027
    - IVDR Class B and A (sterile device) medical devices (However, medical devices declared conformity under IVDD (Directive 98/79/EC) before May 26, 2022)

Conformity assessment procedure for Class A grade products (Article 48)

  • 1) Check the applicable EN, ISO, IEC standards of the product
  • 2) Reflecting the standard in the design
  • 3) Product risk analysis (EN ISO14971)
  • 4) Testing and Verification
  • 5) Preparation of technical document (TD) – Annex II & III
  • 6) QMS - Annex IX or Production QA - Annex XI (procedures for sterile devices only)
  • 7) EU Declaration Of Conformity - Annex IV
  • 8) CE Marking - Annex V
  • 9) European representative selection and contract
  • 10) Report to Europe
  • 11) Registration number
  • 12) EUDAMED registration

Preparation of Technical Documentation

Just as a “technical document” must be prepared according to the Medical Device Act in order to manufacture medical devices in Korea, “technical document” must be prepared to attach the CE mark to medical devices. Therefore, the manufacturer must prepare a technical document (TD) according to Annex II & III. In addition, manufacturers and their European representatives must retain the technical documentation for at least 10 years after the last medical device to which the EU Declaration of Conformity has been applied, regardless of the validity period, after placing it on the market, and must be able to submit it to the competent European authorities. The content regulations to be included in the technical documentation are as follows.

  • 1) General
    State that the contents are technical confidential information of the company, document management status, preparation/approval and date, revisions, table of contents, company introduction and related standards
  • 2) Product Description
    Product overview/name/model name/classification/grade/purpose of use/user/UDI information/working principle/comparative data of equivalent items, etc.
  • 3) Information provided by the manufacturer
    Labels and Instructions
  • 4) General safety performance requirements
    Documents and reports (risk management (EN ISO14971), labels and labeling (EN ISO 18113-1, 15223-1, etc.), analytical performance (CLSI), clinical performance according to the requirements of GSPR (General Safety and Performance Requirements) (ISO 20916), suitability for use (EN IEC 62366), CS, etc.)
  • 5) Design information
    Design and development process and matrix, list of raw materials (name of raw material, grade, type, applicable standard (ISO, EN, IEC, KS), chemical substance (MSDS, Technical data)), etc.
  • 6) Manufacturing/QC process chart
    Flowchart preparation, related document number and storage location
  • 7) Test report
    Data that the applicable standards are met, and that the requirements are met when used in combination with other devices
  • 8) Validation result
    Sterilization, software validation, cleanroom validation, packaging and transportation validation
  • 9) Risk analysis
    Risk analysis report according to EN ISO 14971
  • 10) Clinical data
    Consists of documents on safety and efficacy (thesis, academic journal, etc.) according to Annex XIII, comparison with similar products, sales and customer complaint records, etc.
  • 11) Labels and Packaging
    Prepared in consideration of EN ISO 18113-1, 15223-1, applicable product standards, and Annex V, and also explain the dimensions and material of the packaging box
  • 12) Declaration of Conformity
    EC Declaration of Conformity according to Annex IV
美国 CERT 可以通过与相关组织合作，提供专业的技术支持，以满足客户在欧洲（EU）CE/MDD（MDR）方面的需求和法律要求。公司有信心通过实施欧洲CE标志标准成长为全球性公司。