Medical Devices CE MDR

Europe Medical Devices Product Certification (CE MDR (Medical Devices Regulation (EU) 2017/745)

Europe Medical Devices Regulation

CE MDR Certification

Since 1999, all medical devices exported to Europe must be equipped with CE Mark, and the acquisition of CE Mark by domestic medical device manufacturers is a prerequisite for European exports, and the ICMC (International Certification Management Center Co., Ltd.) has provided many CE MDD/MDR technology advice to domestic medical device manufacturers.
CE MDD/MDR must meet the EU requirements for the product through product safety and reliability tests, and it takes longer than CE Mark for general products because certification review of the quality management system through production system verification (ISO13485:2016 certification) is a necessary condition. In order to acquire CE Mark, the quality system stipulated in ISO13485 standard is established and operated. The existing Directive 93/42/EEC for Medical Devices (MDD) Medical Device Guidelines have been fully enforced under the Medical Devices Regulation (EU) 2017/745) Medical Device Act since May 26, 2021.

Major Changes in CE MDR

• Integrate Direct 93/42/EEC for Medical Device (MDD) and AIMDD (Direct 90/385/EEC for Active Implantable Medical Device)
• Expanding the scope of application: Non-medical products (Annex XVI)
• Reinforcement of standards for designation and supervision of a Notified Body
• Disclosure of safety and clinical performance through the EUDAMED database, etc.
• Reinforcement of post-market surveillance requirements for manufacturers
• Enhanced traceability of medical devices (UDI and EUDAMED)
• Reinforcement of clinical evaluation requirements
• Update on the rating system update
• Establishment of an MDCG agency that manages Notified Bodies (NB) and generates guidance documents as an independent EU agency

CE MDD / MDR Regulatory Comparison

Application of UDI Introduction by Class

Considerations for obtaining CE MDR

• Check that your product falls within the scope of medical devices as defined by the European Medical Device Act (EU), MDR 2017/745).
• You must check whether your product belongs to in medical device classes (Class I, Class Im, Class Is, Class Ir, Class IIa, Class lb, Class III) defined in Annex VIII of European Medical Device Act (EU), MDR 2017/745).
• Your product must follow the Conformity Assessment Procedure of Article 52 of the European Medical Device Act (EU), MDR 2017/745) applicable.

Effect of CE MDR Certification

CE MDR (Medical Device Regulation (EU) 2017/745) Medical Device Act consists of a total of 10 Chapters, 123 Articles and 17 Annexes. Definition, classification, certification procedures for medical devices, general safety and performance requirements (GSPR) for medical devices, regulatory requirements for shipment to the market, and matters to be reported to European authorities are published.
Therefore, CE Mark is essential to distribute medical devices in Europe. According to the risk of medical devices, in the case of Class Ⅰ, a Technical Documentation (TD) must be prepared and reported to the Food and Drug Administration of European countries. In the case of Class Ⅱ and Ⅲ, CE Mark can be affixed after being evaluated by a Notified Body designated by the European Ministry of Health and Welfare.
CE MDR includes documents, reports, and systems that must be submitted, reported, registered, or reviewed with European Competent Authority or Notified Body, in addition to regulations to be followed by in vitro diagnostic medical device manufacturers, Authorized Representative, importers, and distributors. If a medical accident occurs due to shipment of a product within Europe, a strict vigilance system is required from the initial report to the final report. Therefore, the following effects can be expected by obtaining CE Mark for companies related to medical devices.

Conformity assessment procedure for Class I

EC DOC(EU Declaration of conformity)

Class I products are regulated by Article 19 and Annex IV to comply with their own certification procedures, so after completion of the technical document, the name, address, classification rules, product name, corresponding certification authority, date, and representative's signature, and CE mark can be attached.
At this time, you must designate a Authorized Representative with an address in Europe and report it to the European Food and Drug Administration.

Conformity assessment procedure for Class IIa and Class IIb

For medical devices of Class Im, Class Is, Class Ir, and Class II or higher, quality system certification procedures are added to the procedures corresponding to the first-class procedures.
Although there are no regulations on these specifications in CE MDR, most certification agencies require DMFs for certification of these specifications, so you must prepare for them and apply for examination.

COC(Certificate of conformity)

In 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 Notified Body after the evaluation by the Notified Body.

Write Technical Documentation (TD)

Just as a “technical document” must be prepared in accordance with the Medical Device Act to manufacture medical devices in Korea, “technical documentation” must be prepared to attach the CE mark to medical devices. Therefore, the manufacturer must prepare a technical documentation (TD) according to Annex II. In addition, the manufacturer and the Authorized Representative must retain the technical documentation for at least 10 years regardless of the expiration date after the medical device(at least 15 years for implantable devices) to which the EU Declaration of Conformity has been applied is placed 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.

CE MDR Medical Device Classification System

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 divided into four classes.

Classification of medical devices : Classification based on 22 rules according to Annex VIII

• Non – Invasive device : Rule 1~4
• Invasive Device : Rule 5~8
• Active Device : Rule 9~13
• Special Rule : Rule 14~22

CE MDR Explanation of terms

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