Anwendungsbereich des Regulatory Essentials
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)
Manufacturer, Importer, Distributor, B2C products, B2B products
Geltende Rechtsvorschriften:
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)
Nationale Anwendungsebene:
European Economic Area (EU + Iceland, Lichtenstein, Norway)
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
Published 2024-01-03 by Anette Dunkel-Reinboth and Torsten Sahm
Last change 2025-06-16 by Anette Dunkel-Reinboth: Hints, In Vitro Diagnostic (IVD)
Inhalt des Regulatory Essentials
| Responsible actors |
Hier erhalten Sie textbasierte Informationen
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)?
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| Regulatory market access conditions for the actor(s) |
Hier erhalten Sie textbasierte Informationen
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)
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| Penalty by this legislation |
Hier erhalten Sie textbasierte Informationen
What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?
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| Exemption clauses |
Hier erhalten Sie textbasierte Informationen
Exempted devices/products or industry sectors.
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| Sub-federal legislation of states/counties |
Hier erhalten Sie textbasierte Informationen
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.
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| FTA/MRA status with EU |
Hier erhalten Sie textbasierte Informationen
Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?
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| Authority |
Hier erhalten Sie zugehörige weiterführende Links
Name of the authority for approval, registration, market surveillance and/or enforcement
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| Market surveillance authority |
Hier erhalten Sie zugehörige weiterführende Links
Name of the authority for market surveillance and/or enforcement
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| Link/Reference to other reference document(s) |
Hier erhalten Sie zugehörige weiterführende Links
|
| Link/Reference to other reference document(s) |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
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| Comment on the comparability to EU legislation |
Hier erhalten Sie textbasierte Informationen
|
| Abbreviations |
Hier erhalten sie eine Tabelle
Important abbreviations which are special for this legislation or theme.
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| Hints |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
Specific recommendations, information or most common mistakes
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Formal and administrative requirements
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| Registration at related authority required? |
Hier erhalten Sie textbasierte Informationen
Product registration?
Manufacturer registration?
Importer / Representative registration?
if required.
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| Registration at related authority required? |
Hier erhalten Sie zugehörige weiterführende Links
Product registration?
Manufacturer registration?
Importer / Representative registration?
if required.
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| Local representative legally required? |
Hier erhalten Sie textbasierte Informationen
[Yes/No]
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| IMDRF Membership |
Hier erhalten Sie zugehörige weiterführende Links
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.
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| Database Entry required |
Hier erhalten Sie zugehörige weiterführende Links
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Equipment authorization (approval process)
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| Classification Rules |
Hier erhalten Sie textbasierte Informationen
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| Nomenclature/Borderline Rules |
Hier erhalten Sie zugehörige weiterführende Links
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| Approval process (conformity assessment procedure) |
Hier erhalten Sie textbasierte Informationen
Means each legally required approval process prior placing on the market, importation or putting into service
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| Conformance document(s) to show compliance to the authority |
Hier erhalten Sie textbasierte Informationen
e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)
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| Conformance document validity and renewal |
Hier erhalten Sie textbasierte Informationen
Validity for Conformance document name mentioned. For mandatory certification validity is important.
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| Which documents are required by an approval body? |
Hier erhalten Sie textbasierte Informationen
e .g. formal application
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| Is a factory inspection legally required |
Hier erhalten Sie textbasierte Informationen
|
| Hints |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
Specific recommendations, information or most common mistakes
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| Specific requirements for testing |
Hier erhalten Sie textbasierte Informationen
e. g. is an accredited test lab. mandatory, limits, test samples, product description
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| General information to the application of standards |
Hier erhalten sie eine Tabelle
e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"
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| National Standardisation Organisation |
Hier erhalten Sie zugehörige weiterführende Links
Link to organisation
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| Source for standards for conformity assessment |
Hier erhalten Sie zugehörige weiterführende Links
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| Are national standards based on IEC/ISO standards? |
Hier erhalten Sie textbasierte Informationen
Undetailed information
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| Is in-country testing legally required? |
Hier erhalten Sie textbasierte Informationen
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| Acceptance of foreign test reports |
Hier erhalten Sie textbasierte Informationen
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Regulatory labelling, markings and user information
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| Regulatory label (mandatory) |
Hier erhalten Sie ein Foto oder Diagram
e. g. product label
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| UDI marking |
Hier erhalten Sie ein Foto oder Diagram
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| Regulatory e-labelling allowed? |
Hier erhalten Sie textbasierte Informationen
e. g. put the regulatory information and labels in a software menu
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| Required information on the product and/or packaging |
Hier erhalten Sie ein Foto oder Diagram
e. g. address of the manufacturer/importer, serial number
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| User instructions language(s) |
Hier erhalten Sie textbasierte Informationen
Regulated by the legal provisions
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| User instructions language(s) |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
Regulated by the legal provisions
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| User instruction requirements and specific compliance notes |
Hier erhalten sie eine Tabelle
Form, sentence inside, simple text.
E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste
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| Medical Device Symbols |
Hier erhalten Sie textbasierte Informationen
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| Digital user documentation allowed? |
Hier erhalten Sie textbasierte Informationen
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?
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Allgemeine Informationen
European Economic Area (EU + Iceland, Lichtenstein, Norway)
Code, Kontinent, Wirtschaftsraum
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