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全球 RA 许可证
欧洲
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.
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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