Scope of this ESSENTIAL

This ESSENTIAL focuses on cybersecurity for medical devices. This ESSENTIAL describes the legal obligations for manufacturers of medical devices in the European Union, based on the - Regulation (EU) 2017/745 and its amendments - MDCG (EU Medical Device Coordination Group) documents'

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

Scope of legislation

Cybersecurity requirements contained in MDR Annex I (MDCG 2019-16 rev. 1)'

Link/Reference to other reference document(s)

Here you will get textual information

Link/Reference to other reference document(s)

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

Scope of legislation

Here you will get a image or chart

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)?

Process-related requirements?

Here you will get textual information

Product-related requirements?

Here you will get textual information

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 related hyperlink(s) 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?

Adequate third countries to transfer data

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

Adequate third countries to transfer data

Here you will get related hyperlink(s)

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 textual information Name of the authority for market surveillance and/or enforcement

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.

Local representative legally required?

Here you will get textual information [Yes/No]

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

Is the IECEE CB Scheme accepted by the authority/approval body?

Here you will get related hyperlink(s) "[Yes/ No / no information available] [Text] Information (website)"

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

Hint to voluntary certification scheme

Here you will get textual information If a important voluntary certification schemes exists, one link will be given. Important voluntary schemes are for example: UL, CSA, VCCI (Japan)

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)

National Standardisation Organisation

Here you will get textual information Link to organisation

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

Hints

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

Regulatory labelling, markings and user information

Regulatory label (mandatory)

Here you will get textual information 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

Required information on the product and/or packaging

Here you will get textual information 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 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?

Warnings, symbols

Here you will get textual information e. g. ANSI Z 535.4

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