Regulatory ESSENTIAL
Europ. Economi. - Medical Devices

Scope of this ESSENTIAL

This ESSENTIAL describes the regulatory requirements of medical devices in the European Union, based on the - Regulation (EU) 2017/745 and its amendments - MDCG (EU Medical Device Coordination Group) documents Definition of "Medical Device" (Regulation (EU) 2017/745 - Article 2) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, - investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, - providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, Health products are classified into four risk classes, according to the risk associated with their use. ANNEX VIII - CLASSIFICATION RULES, Chapter III, Rule 1 - 22. Class I Class IIa Class IIb Class III For cybersecurity/software topics of medical devices, see: ESSENTIAL EEA Cybersecurity, PCT "Medical Products". Not in scope of this CRF: - In-Vitro Diagnostics (see: ESSENTIAL EEA In-Vitro Diagnostics)'

Abbreviations

here you will get a table Important abbreviations which are special for this legislation or theme.

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)?

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 textual information 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)

Comment on the comparability to EU legislation

here you will get textual information

Hints

here you will get textual information Specific recommendations, information or most common mistakes

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 textual information 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 textual information

Equipment authorization (approval process)

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

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

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

National Standardisation Organisation

here you will get related hyperlink(s) Link to organisation

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

Regulatory e-labelling allowed?

here you will get textual information e. g. put the regulatory information and labels in a software menu

UDI marking

here you will get textual information

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 related hyperlink(s) Regulated by the legal provisions

User instruction requirements and specific compliance notes

here you will get textual information Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

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