Regulatory ESSENTIAL



Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

In vitro diagnostic; IVD devices; IVD devices; CMDE; Electronic registration; NMPA; UDI regulation; UDI Code; IMDRF; Classification Rule; ISO 15223-1 symbol; vigilance

Scope: This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostics medical devices in the European Union, based on the - Regulation (EU) 2017/746 and its amendments - MDCG (EU Medical Device Coordination Group) documents Definition of "‘In-Vitro Diagnostic medical device" acc. to Article 2 of Regulation (EU) 2017/746: "In-Vitro Diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: a) concerning a physiological or pathological process or state; b) concerning congenital physical or mental impairments; c) concerning the predisposition to a medical condition or a disease; d) to determine the safety and compatibility with potential recipients; e) to predict treatment response or reactions; f) to define or monitoring therapeutic measures IVD products are classified into four risk classes, according to the risk associated with their use. ANNEX VIII - CLASSIFICATION RULES, Chapter 2, Rule 1 - 7. Class A Class B Class C Class D Not in scope of this CRF: - Medical Devices (see: ESSENTIAL EEA Medical Devices)

Stakeholders: Manufacturer, Importer, Distributor, B2C products, B2B products
Legislation in force: Regulation (EU) 2017/746 repeals: - Directive 98/79/EC - Commission Decision 2010/227/EU All cited Articles are part of the Regulation (EU) 2017/746. Regulation (EU) 2017/746, Article 110 is amended as follows: Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates: a) 26 May 2025, for class D devices; b) 26 May 2026, for class C devices; c) 26 May 2027, for class B devices; d) 26 May 2027, for class A devices placed on the market in sterile condition Regulation (EU) 2017/746 is amended as follows: (1) in Article 110, paragraph 4 is replaced by the following: 4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service.; (2) in Article 112, the second paragraph is replaced by the following: As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs. Scope of this amending Regulation: Article 40 - Monitoring and re-assessment of notified bodies - the timing of the first complete re-assessment of a notified body after notification has been extended to 5 years (former: 3 years) - the frequency of subsequent complete re-assessments has also been extended to 5 years (former: 4 years)

Application national:

Countries: Image for EEA European Economic Area (EU + Iceland, Lichtenstein, Norway),  
Comment on the comparability to EU legislation: not applicable...
Status: Published 2024-01-03 by Anette Dunkel-Reinboth and Torsten Sahm
Last change 2024-06-04 by Anette Dunkel-Reinboth: IMDRF Membership, In Vitro Diagnostic (IVD)
ROGER WILLCO ID: #cf74
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Scope of this ESSENTIAL
This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostics medical devices in the European Union, based on the
- Regulation (EU) 2017/746 and its amendments
- MDCG (EU Medical Device Coordination Group) documents

Definition of "‘In-Vitro Diagnostic medical device" acc. to Article 2 of Regulation (EU) 2017/746:
"In-Vitro Diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
a) concerning a physiological or pathological process or state;
b) concerning congenital physical or mental impairments;
c) concerning the predisposition to a medical condition or a disease;
d) to determine the safety and compatibility with potential recipients;
e) to predict treatment response or reactions;
f) to define or monitoring therapeutic measures

IVD products are classified into four risk classes, according to the risk associated with their use.
ANNEX VIII - CLASSIFICATION RULES, Chapter 2, Rule 1 - 7.
Class A
Class B
Class C
Class D

Not in scope of this CRF:
- Medical Devices (see: ESSENTIAL EEA Medical Devices)'

Analysis of regulatory requirements

Legislation in force for this PCT
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation
Scope of Regulation (EU) 2017/746

CHAPTER I - Introductory Provision (Scope and Definitions, Regulatory status of products, Genetic information, counselling and informed consent)
CHAPTER II - Making Available on the Market and Putting into Service of Devices, Obligations of Economic Operators, CE Marking, Free Movement
CHAPTER III- Identification and Traceability of Devices, Registration of Devices and of Economic Operators, Summary of Safety and Clinical Performance, European Database on Medical Devices
CHAPTER IV - Notified Bodies
CHAPTER V - Classification and Conformity Assessment
CHAPTER VI - Clinical Evidence, Performance Evaluation and Performance Studies
CHAPTER VII - Post-Market Surveillance, Vigilance and Market Surveillance
CHAPTER VIII - Cooperation between Member States, Medical Device Coordination Group, EU Reference Laboratories and Device Registers
CHAPTER IX - Confidentiality, Data Protection, Funding and Penalties
CHAPTER X - Final provisions

Annexes:
I - General safety and performance requirements
II - Technical documentation
III - Technical documentation on post-market surveillance
IV - EU declaration of conformity
V - CE marking of conformity
VI - Information to be submitted upon the registration of devices and economic operators in accordance with Articles 26(3) and 28, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 25 and 26 and the UDI system
VII - Requirements to be met by notified bodies
VIII - Classification rules
IX - Conformity assessment based on a quality management system and on assessment of technical documentation
X - Conformity assessment based on type examination
XI - Conformity assessment based on production quality assurance
XII - Certificates issued by a notified body
XIII - Performance evaluation, performance studies and post-market performance follow-up
XIV - Interventional clinical performance studies and certain other performance studies
XV Correlation table'

Responsible actors
Here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
Here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Penalty by this legislation
Here you will get textual information

What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

Exemption clauses
Here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
Here you will get textual information

E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
Here you will get textual information

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
Here you will get related hyperlink(s)

Name of the authority for approval, registration, market surveillance and/or enforcement

Market surveillance authority
Here you will get related hyperlink(s)

Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
Here you will get related hyperlink(s)

Link/Reference to other reference document(s)
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Comment on the comparability to EU legislation
Here you will get textual information

Abbreviations
Here you will get a table

Important abbreviations which are special for this legislation or theme.

Hints
Here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
Here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Registration at related authority required?
Here you will get related hyperlink(s)

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
Here you will get textual information

[Yes/No]

IMDRF Membership
Here you will get related hyperlink(s)

Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Database Entry required
Here you will get related hyperlink(s)

Equipment authorization (approval process)

Classification Rules
Here you will get textual information

Nomenclature/Borderline Rules
Here you will get related hyperlink(s)

Approval process (conformity assessment procedure)
Here you will get textual information

Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority
Here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
Here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
Here you will get textual information

e .g. formal application

Is a factory inspection legally required
Here you will get textual information

Hints
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing
Here you will get textual information

e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
Here you will get a table

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

National Standardisation Organisation
Here you will get related hyperlink(s)

Link to organisation

Source for standards for conformity assessment
Here you will get related hyperlink(s)

Are national standards based on IEC/ISO standards?
Here you will get textual information

Undetailed information

Is in-country testing legally required?
Here you will get textual information

Acceptance of foreign test reports
Here you will get textual information

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get a image or chart

e. g. product label

UDI marking
Here you will get a image or chart

Regulatory e-labelling allowed?
Here you will get textual information

e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging
Here you will get a image or chart

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
Here you will get textual information

Regulated by the legal provisions

User instructions language(s)
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Regulated by the legal provisions

User instruction requirements and specific compliance notes
Here you will get a table

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Medical Device Symbols
Here you will get textual information

Digital user documentation allowed?
Here you will get textual information

User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?


Code, ContinentEEA,
Economic Area
Official Language24 official languages
Standard Institute
HS Codemember






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