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What is a Medical Device as defined by CE?

Instruments, devices, equipment, software, implants, reagents, materials or other medical articles, used alone or in combination, intended for human use by the manufacturer for the purposes of: Includes software and software necessary for the use of medical devices.

  • 1) Diagnosis, prevention, audit, prediction, prediction, treatment or alleviation of disease
  • 2) Diagnosis, monitoring, treatment, alleviation or correction of an injury or disability condition;
  • 3) Investigation, replacement or modification of anatomical structures or bodily/pathological processes or bodily conditions
  • 4) Device for pregnancy management or pregnancy support
  • 5) Obtaining information from examination of specimens from humans, including donation of organs, blood and tissues from the human body (IVD)
  • 6) By pharmacological, immunological and metabolic means, the intended main action inside or on the human body is not intended, but it can receive functional assistance.

• CE Marking application standards for medical devices

MDD (Directive 93/42/EEC for Medical device) and AIMDD ((Directive 90/38/EEC for Active Implantable Medical device) integration

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

CoC : In the case of Class Im, Class Is, Class Ir and Class II or higher, the system certificate and CE mark certificate are issued by the relevant certification body after the certification body audit.

DoC : Class I products are stipulated in Article 19 and Annex IV to follow the self-certification procedure. Therefore, after completing the technical documentation, the name, address, written classification rule, product name, relevant certification body, date, signature, etc. of the representative are described. You can attach the CE mark by writing your own document.

•  At this time, you must designate a European agent with an address in Europe and report it to the European Food and Drug Administration.

Applicable countries
- 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, Netherlands
- EFTA (European Free Trade Association): Switzerland, Liechtenstein, Norway, Iceland
- EU Associate Countries: Bulgaria, Croatia, Romania, Turkey

• Medical Device Classification

Classification system: Class I, (Class Im, Class Is, Class Ir), Class IIa, Class llb, Class III
* Im (Measurement), Is(Sterile), Ir (Reuse)
Based on the potential risk, it is classified into 4 grades.
Classification of medical devices: Classification based on 22 rules according to Annex VIII

Non – Invasive device (non-implantable medical device): Rule 1-4

Invasive Device: Rule 5~8

Active Device (active medical device): Rule 9~13

Special Rule: Rule 14~22

• CE MDD/MDR Regulatory Comparison

division CE MDD CE MDR
legal provisions 23 Articles 10 Chapters
123 Articles
annex 12 Annexes 17 Annexes
form of law Directive Regulation

• When to introduce UDI by grade

CE MDR Class III and implantable devices Class II a and Class II b Class I
apply to label From May 26, 2021 From May 26, 2023 From May 26, 2025
reusable product direct application From May 26, 2023 From May 26, 2025 From May 26, 2027

Certification procedure for Class I grade products

  • 1) Check the applicable EN, ISO, IEC standards of the product
  • 2) Establishment of quality system (ISO13485, Post Market Surveillance (PMS) and reporting system (Vigilance))
  • 3) Reflecting the standard in the design
  • 4) Product risk analysis (EN ISO14971)
  • 5) Testing and Verification
  • 6) Preparation of technical document (TD)
  • 7) EU Declaration Of Conformity
  • 8) CE Marking
  • 9) European representative selection and contract
  • 10) Report to Europe
  • 11) Registration number
  • 12) EUDAMED registration

Preparation of technical documents (TD)

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 the Technical Documentation according to Annex II. In addition, manufacturers and their European representatives must retain the technical documentation “at least 10 years after the last medical device to which the EU Declaration of Conformity has been applied has been placed on the market and, in the case of implantable devices, for at least 15 years, and 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, efficacy/characteristics, product description, photo/design/circuit diagram, etc., user manual, catalog
  • 3) General safety performance requirements
    Documents and reports according to the requirements of GSPR (General Safety and Performance Requirements) (Risk Management (EN ISO14971), Labels and Markings (EN1041, EN ISO 15223-1) Electrical Commons (EN60601-1, EN60601-1-2) , software validity (EN IEC 62304), common sterilization (EN556), biocompatibility (EN ISO10993), compatibility for use (EN IEC 62366), etc.)
  • 4) Raw material list
    Name of raw material, grade, type, applicable standard (ISO, EN, IEC, KS) Chemical substance (MSDS, Technical data), electronic component (Spec approval-CE, UL), Test report
  • 5) Manufacturing/QC process chart
    Flowchart preparation, related document number and storage location
  • 6) Test report
    Data that the applicable standards are met, and that the requirements are met when used in combination with other devices
  • 7) Validation result
    Sterilization, software validation
  • 8) Risk analysis
    Risk analysis report according to EN ISO 14971
  • 9) Clinical data
    It consists of documents on safety and effectiveness (thesis, academic journals, etc.) according to MEDDEV 2.7.1, MDR Annex XVI, XV, comparison with similar products, sales and customer complaint records, etc.
  • 10) Labels and packaging
    Prepared in consideration of EN1041, EN ISO 15223-1, applicable product standards, and Annex V, and also explain the dimensions and material of the packaging box
  • 11) 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。