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CE IVDR

In Vitro Diagnostic Devices CE IVDR

Europe In Vitro Diagnostic Devices Product Certification (CE IVDR (In Vitro Diagnostic Devices Regulation (EU) 2017/746)

Europe In Vitro Diagnostic Devices Regulation



CE IVDR Certification

Since 1999, all in vitro diagnostic medical devices exported to Europe are required to be affixed with the CE Mark, and domestic in vitro diagnostic medical device manufacturers' CE Mark acquisition is an essential requirement for export to Europe. ICMC (International Certification Management Center Co., Ltd.) provides many CE IVDD / IVDR technical advice to domestic in vitro diagnostic 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. The existing IVDD (Directive 98/79/EC for in vitro diagnostic Medical devices) Directive will be implemented as the IVDR (Regulation (EU) 2017/746) In Vitro Diagnostic Medical Devices Act after May 26, 2022. It will be implemented by introducing a customized transition period according to the class of medical device.



When to apply CE IVDR

  • Apply IVDR from May 26, 2022
    - Class A (non-sterile equipment)
    - In vitro diagnostic medical devices to be newly registered after May 26, 2022

  • Apply IVDR from May 26, 2025
    - In vitro diagnostic medical device evaluated by Notified Body under IVDD (Directive 98/79/EC)
    - IVDR Class D in vitro diagnostic medical device (However, in vitro diagnostic medical device declared conformity under IVDD (Directive 98/79/EC) before May 26, 2022)

  • IVDR effective from May 26, 2026
    - IVDR Class C in vitro diagnostic medical device (However, in vitro diagnostic medical device declared conformity under IVDD (Directive 98/79/EC) before May 26, 2022)

  • IVDR effective from May 26, 2027
    - IVDR Class B and A (sterile device) in vitro diagnostic medical device (However, in vitro diagnostic medical device declared conformity under IVDD (Directive 98/79/EC) before May 26, 2022)


Major Changes in CE IVDR

  • Expansion of scope of application: About 8% of existing in vitro diagnostic medical devices obtained CE certificate through conformity assessment from Notified Body under IVDD (Directive 98/79/EC), but IVDR (Regulation (EU) 2017 /746), about 80% are under the control of the Notified Body, and the majority experience the Notified Body's conformity assessment for the first time.
  • Converted to a classification system based on Classification Rules and classified into 4 classes according to the degree of risk
  • Responsibilities of economic operators (Authorized Representative, importers, distributors, PRRCs, manufacturers) should be specified and registered and published through the European database (EUDAMED)
  • Strengthening standards for designation and supervision of Notified Body (NB)
  • Disclosure of safety and clinical performance overview through EUDAMED database
  • Enhancing post-market surveillance requirements for manufacturers
  • Enhanced traceability of in vitro diagnostic medical devices (UDI and EUDAMED)
  • Reinforcement of requirements for clinical evaluation
  • Established the MDCG body, an independent EU body, to create NB management and guidance documents


CE IVDD / IVDR Regulatory Comparison

Category CE IVDD CE IVDR
provisions of the law
24 Article
10 Chapter
113 Article
annex
10 Annexes
15 Annexes
Page
43 pages
157 pages
form of law
Directive
Regulation


Considerations for obtaining CE IVDR

  • Check that your product falls within the scope of in vitro diagnostic medical devices as defined by the European In Vitro Diagnostic Medical Devices Act, IVDR (EU) 2017/746.
  • You must check whether your product belongs to in vitro diagnostic medical device classes (Class D, Class C, Class B, Class A) defined in Annex VIII of the European In Vitro Diagnostic Medical Device Act, IVDR (EU) 2017/746).
  • Your product must follow the Conformity Assessment Procedure of Article 48 of the European In Vitro Diagnostic Medical Devices Act, IVDR (EU) 2017/746) applicable.



Effect of CE IVDR Certification

CE IVDR (In vitro Medical Device Regulation (EU) 2017/746) In Vitro Diagnostic Medical Device Act consists of a total of 10 Chapters, 113 Articles and 15 Annexes. Definition, classification, certification procedures for in vitro diagnostic 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 in vitro diagnostic medical devices in Europe. According to the risk of in vitro diagnostic medical devices, in the case of Class A (non-sterile devices), a Technical Documentation (TD) must be prepared and reported to the Food and Drug Administration of European countries. In the case of Class B, C, and D, CE Mark can be affixed after being evaluated by a Notified Body designated by the European Ministry of Health and Welfare.
CE IVDR 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 in vitro diagnostic medical devices.


1
Provide consumers with safe products by meeting general safety performance requirements (GSPR)
2
No restrictions on export to EU member states (EU requirements – CE Mark mandatory for all products within EU member states)
3
By attaching the CE Mark to products, export attempts to countries other than the EU and export competitiveness are strengthened
4
Eliminate the risk of litigation through product safety
5
Improving company, product and brand image and credibility



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

1
Check the applicable EN, ISO, IEC standards of the product
2
Reflect the standard in the design
3
Product risk analysis (EN ISO14971)
4
Testing and Verification
5
Preparation of technical documentation (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


EC DOC(EU Declaration of conformity)

Self-declaration is regulated in Article 48 and Annex IV (EU DOC) and Annex V (CE Marking). Therefore, after completing the writing of the technical documentation, you can write your own document that describes the company name, address, written classification rule, product name, relevant Notified Body, date, signature, etc. and attach the CE mark.
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 B grade products

For Class B grade, the quality system certification procedure and technical documentation procedure are added to the procedure corresponding to the Class A grade as follows.


  • Full QMS - Annex IX, 1 & 3
  • Writing technical documentation (TD) – Annex IX 4.4 ~ 4.8

In CE IVDR, you must prepare for this and apply for an audit.




Conformity assessment procedure for Class C grade products

For Class C, the quality system certification procedure and technical documentation procedure are added to the procedure corresponding to the Class A grade as follows.


  • Full QMS - Annex IX
  • Writing technical documentation (TD) – Annex IX 5.2
  • In case of companion diagnosis – Annex X 3(k)

     or

  • Production QA - Annex XI
  • Type Examination (TD) – Annex X
  • In case of companion diagnosis – Annex X 3(k)

In CE IVDR, you must prepare for this and apply for an audit.




Conformity assessment procedure for Class D grade products

For Class D, the quality system certification procedure and technical documentation procedure are added to the procedure corresponding to the Class A grade as follows.


  • Full QMS - Annex IX
  • Writing technical documentation (TD) – Annex IX 5.1
  • Batch Verification

     or

  • Production QA - Annex XI
  • Type Examination(TD) – Annex X
  • Batch Verification

If there is no CS, consultation with the expert panel is required according to Sec. 4.9 of Annex IX or Sec. 3 of Annex X.



COC(Certificate of conformity)

In case of Class B 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 In Vitro Diagnosis Medical Device Act to manufacture in vitro diagnostic medical devices in Korea, “technical documentation” must be prepared to attach the CE mark to in vitro diagnostic medical devices. Therefore, the manufacturer must prepare a technical documentation (TD) according to Annex II & III. 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 last in vitro diagnostic medical device 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.


1
General requirements
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/action principle/comparative data of equivalent items, etc.

3
Information provided by the manufacturer
Labels and Instructions

4
General safety performance requirements
Documents and reports in accordance with the requirements of GSPR (General Safety and Performance Requirements) (Risk Management (EN ISO14971), labels and markings (EN ISO 18113-1, 15223-1, etc.), analytical performance (CLSI), clinical performance (ISO 20916), usability(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 safety and efficacy documents (thesis, academic journals, 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 describe the dimensions and material of the packaging box

12
Declaration of Conformity
EC Declaration of Conformity according to Annex IV



CE IVDR In Vitro Diagnostic Medical Device Classification System

Classification system : Class D, Class C, Class B, Class A
Based on the potential risk, it is divided into four classes.

  • Class A
  • Class B
  • Class C
  • Class D
CE IVDR

Classification of in vitro diagnostic medical devices: Classification based on 7 rules according to Annex VIII

Rules Contents Class Example
Rule 1
 - Blood screening
- High risk disease
D
 Malaria
syphilis
Rule 2 - Blood or tissue compatibility
C/D
 Determining blood groups Anti-Duffy and Anti-Kidd(D)
Rubella(C)
Chlamydia(C)
Rule 3 - Infectious disease / Cancer testing
- Companion diagnostics / Genetic testing
- Congenital screening
C
 Phenylketonuria
PSA
Thyroid Cancer marker assay
Rule 4 - Self-testing
B/C
 Self-testing rapid test IVD for cholesterol level(B)
Self-test strips for blood glucose(C)
Rule 5 - Specific IVD reagents, Instruments, Specimen receptacles
A
 Wash Buffer
Rule 6 - Non of the other rules
B
 Clostridium difficile
Rule 7 - Controls no assigned values
B
 Control materials used to verify the migration of immunochromatographic assays



CE IVDR Explanation of terms

1
EUDAMED
In CE IVDR, the European database is introduced to ensure traceability of in vitro diagnostic medical devices and to facilitate the flow of information between in vitro diagnostic medical device manufacturers and users, as well as certification bodies, the European Union and the European Commission. EUDAMED's management scope includes not only a unique number called UDI (Unique Device Identification) for product registration, but also device registration, certification bodies and certificates, clinical trials, economic operator registration, Vigilance, PMS, and Market Surveillance.

2
GSPR (General Safety and Performance Requirements)
For general safety performance requirements, the Essential Requirement Checklist of Annex I of CE IVDR has been updated to GSPR according to Annex I of CE IVDR.

3
PRRC (Person Responsible for Regulatory Compliance)
The person responsible for regulatory compliance is a person responsible for compliance with the required expertise in the field of in vitro diagnostic medical devices for each manufacturer, and must have at least one person in the organization. That is, in common with the manufacturer and the European representative, they must have quality, RA experience or related qualifications.

4
Economic Operator
Economic operator is a new concept introduced in IVDR and refers to manufacturers (legal manufacturers), Authorized Representative, importers, and distributors.

5
UDI (Unique Device identification)
It is a medical device unique identification code that provides a consistent and standard way for medical service providers and patients to identify devices during distribution and use, and consists of three main areas.
Basic UDI – DI Basic UDI-DI (Device Identifier) is the primary identifier of the device model, and is DI assigned to the device usage unit level. It is the primary key of UDI database records and is referenced in relevant certificates and EU declarations of conformity.
UDI-DI (Device Identifier) is a unique numeric or alphanumeric code specific to the device model and is also used as an ‘access key’ for information stored in the UDI database.
UDP-PI (Production Identifier) is a numeric or alphanumeric code that identifies a device production unit. This includes serial number, lot number, software identification and date of manufacture or expiration.

6
NB (Notified Body)
As a body conducting conformity assessment made in accordance with CE IVDR, it is a third-party body that has obtained approval from the governments of EU member states and has been registered (notified) with the European Commission for each directive, and issues EU type certificates. These bodies are published by the European Commission.

7
Authorized Representative
means any natural or legal person established within the Union which has received and accepted a written mandate from a manufacturer outside the EU to act on behalf of the manufacturer in relation to the specified work in relation to the manufacturer's obligations under this Agreement under the IVDR Regulations.

8
Importer
means any natural or legal person established within the Union that places devices of third countries on the Union market.

9
Distributor
means any natural or legal person in the supply chain that is not a manufacturer or importer who makes a device available on the market until the point of providing the service.

10
Conformity Assessment
Refers to the process of demonstrating whether the requirements of the IVDR regulation relating to a device have been met.

11
CE marking of conformity or CE marking
means a mark by the manufacturer indicating that the device complies with the applicable requirements set forth in the IVDR Regulations and other applicable co-operative harmonized laws providing for such attachments.

12
PMS (Post-Market Surveillance)
Post-marketing investigation, aimed at confirming the need for manufacturers, in collaboration with other economic actors, to apply the necessary corrective or preventive measures immediately. means any activity undertaken to establish and keep up-to-date with systematic procedures for actively collecting and reviewing experiences to be gained from devices placed on the market, sold or put into use.

13
Market Surveillance
Market surveillance, in vitro diagnostic means activities and measures carried out by competent authorities (health authorities, CA) to ensure that medical devices verify and comply with the requirements set forth in harmonized laws of EU Member States and do not impair aspects of health, safety or protection of the public interest.

14
Specimen receptacle
It refers to a device, regardless of whether or not a vacuum is specifically intended by the manufacturer to primarily store and preserve samples extracted from the human body for the purpose of in vitro diagnostic testing.

15
Device for self-testing
means any device intended by the manufacturer for use by the public, including devices used in test services provided to the public;

16
Device for near-patient testing
It refers to any device that is not intended for self-testing, but is generally intended to be performed by a healthcare professional outside of a laboratory environment close to or next to a patient.

17
Generic device group
It refers to a group of devices that have the same or similar intentions or technologies that allow them to be classified in general without reflecting specific characteristics.

18
Single-use device
Means an in vitro diagnostic medical device intended for use during a single procedure.

19
Falsified device
means any device that falsely displays its identity and/or origin and/or CE marking certificate or documentation relating to the CE marking procedure.

20
Benefit-risk determination
means an analysis of any assessment of the benefits and risks of possible relevance to the use of a device for its intended purpose.

21
Health institution
An institution whose main purpose is to care for or treat patients or to promote public health.

22
Conformity assessment body
Refers to an organization that performs third-party conformity assessment activities such as calibration, testing, certification, and inspection.

23
Harmonised standard
means the European Standard as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012.

24
Common specifications (CS)
Means a set of non-standard technical and/or clinical requirements that provide a means of complying with legal obligations applicable to a device, process or system.




Related major websites

Regulation (EU) 2017/746 – EU Medical Devices Regulation European Medical Device Coordination Group (MDCG) – guidance document on various aspects of IVDR Europa Website EU Harmonized Standard Site Search for Notified Body (NB) – NANDO website EUDAMED