Regulatory ESSENTIAL
Europ. Economi. - In-Vitro Diagnostics

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 licence) 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 licence)

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 licence) 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 licence) 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, Continent	EEA,
Economic Area
Official Language	24 official languages
Standard Institute
HS Codemember