European Authorized Representative

Last updated

A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. The CE certificate and declaration of conformity can only be issued by a company located in the European Union. [1]

Contents

Overview

Regulation of goods manufactured outside the European Union, particularly in the context of consumer product safety, led to the establishment of requirements for EU Authorized Representatives. Under the General Product Safety Regulation (GPSR) — Regulation (EU) 2023/988 — products marketed in the EU must include an Authorized Representative if the manufacturer is located outside the European Union, starting from the 13th of December, 2024. This representative acts as a contact point for competent authorities in EU member states and ensures that the product complies with applicable safety and traceability requirements. [2] [3]

GPSR covers only products that do not fall under other directives. As clarified in the Medical Devices Directive — Directive 93/42/EEC [4] — it is required that alongside the CE mark all products must also have an Authorised Representative. As stated in this amendment, an Authorised Representative should serve as a contact point with the EU member states competent authorities. Medical Device Regulation ("MDR") — Regulation (EU) 2017/745 [5] — and in vitro diagnostic Medical Device Regulation — Regulation (EU) 2017/746 [6] — increase obligations of E.A.R in the field of surveillance of medical devices. [5]

An E.A.R. holds the responsibility to act as a neutral party between the competent authorities and the non EU manufacturers. They must ensure the manufacturer's compliance with the conformity assessment procedure set out in the European directives which apply to the manufacture's product. The EAR must uphold dual accountability with the manufactures if problems or questions arise regarding the product. The E.A.R. must provide their contact information for the manufacturer to place on the products, allowing the E.A.R. to be the primary contact for EU authorities. The E.A.R. is the entity to which the authorities and institutions of the EU Member States may address the obligations set out in the legal requirements for medical devices. An authorised representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer. [7]

European ‘Blue Guide" [8] describes that delegation of an authorised representative should be set out in writing (as an agreement, mandate, or power of attorney) to define contents and limits of tasks. The copy of the agreement should be sent for competent authorities upon request.

Duties of a European Authorised Representative

An E.A.R. observes the manufacturers' compliance with the conformity assessment procedure set out in the European directives which apply to the product.

They ensure the law is met by having Class I medical devices registered with the Competent Authorities before being placed on the market.

They ensure their contact information is available to the manufactures to be placed on all the products they are representing, thus acting as a primary contact for the EU Authorities.

They must notify EU Authorities of all major incidents pertaining to products.

An E.A.R. must understand all EU regulations from each of the EU member states as well as the four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products.

They must keep the product's technical file available at any time for the EU member states authorities and maintain confidentiality with manufacturer's sensitive product information, releasing them only to the appropriate authorities when called upon.

See also

Related Research Articles

<span class="mw-page-title-main">Restriction of Hazardous Substances Directive</span> European Union directive restricting ten hazardous materials

The Restriction of Hazardous Substances Directive 2002/95/EC, short for Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment, was adopted in February 2003 by the European Union.

<span class="mw-page-title-main">CE marking</span> European Declaration of conformity mark

The presence of the logo on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark.

<span class="mw-page-title-main">Registration, Evaluation, Authorisation and Restriction of Chemicals</span> European Union regulation

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006, amended on 16 December 2008 by Regulation (EC) No 1272/2008. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force on 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.

<span class="mw-page-title-main">Medical device</span> Device to be used for medical purposes

A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world. Processes and certifications known as type approval in English are often called homologation, or some cognate expression, in other European languages.

ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.

<span class="mw-page-title-main">Medical Devices Directive</span>

The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.

<span class="mw-page-title-main">Notified body</span>

A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.

ISO 14971Medical devices — Application of risk management to medical devices is a voluntary consensus standard, published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.

<span class="mw-page-title-main">Construction Products Directive</span>

Construction Products Directive (Council Directive 89/106/EEC)(CPD) is a now repealed European Union Directive which aimed to remove technical barriers to trade in construction products between Member States in the European Union.

<span class="mw-page-title-main">Regulation (EU) No. 305/2011</span>

Regulation No. 305/2011 of the European Parliament and of the Council of the European Union is a regulation of 9 March 2011 which lays down harmonised conditions for the marketing of construction products and replaces Construction Products Directive (89/106/EEC). This EU regulation is designed to simplify and clarify the existing framework for the placing on the market of construction products. It replaced the earlier (1989) Construction Products Directive (89/106/EEC).

The Low Voltage Directive (LVD) 2006/95/EC is one of the oldest Single Market Directives adopted by the European Union before the "New" or "Global" Approach. The Directive provides common broad objectives for safety regulations, so that electrical equipment approved by any EU member country will be acceptable for use in all other EU countries. The Low Voltage Directive does not supply any specific technical standards that must be met, instead relying on IEC technical standards to guide designers to produce safe products. Products that conform to the general principles of the Low Voltage Directive and the relevant particular safety standards are marked with the CE marking to indicate compliance and acceptance throughout the EU. Conformance is asserted by the manufacturer based on its conformity assessment.

Market surveillance for products ensures that products on the market conform to applicable laws and regulations. This helps to foster trust among consumers buying products or financial services and protects consumers and professionals from harm from non-compliant products. It also helps companies that comply to stay in business and avoid losing market share to rogue traders.

The Machinery Directive, Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 is a European Union directive concerning machinery and certain parts of machinery. Its main intent is to ensure a common safety level in machinery placed on the market or put in service in all member states and to ensure freedom of movement within the European Union by stating that "member states shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with [the] Directive".

EC Regulation 1223/2009 on cosmetics sets binding requirements for cosmetic products that have been made available on the market within the European Union. Manufacturers of products that fall under the category or cosmetics are required to abide by this regulation as they prepare their initial release of products and while continuing to sell said products within the Member States of the EU.

<span class="mw-page-title-main">Regulation (EU) 2017/745</span> Political regulation

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).

<span class="mw-page-title-main">Regulation (EU) 2017/746</span>

Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices. Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC), the requirement of UDI marking for devices, common specifications, Eudamed registration, and increased post-market surveillance activities.

A custom-made medical device, commonly referred to as a custom-made device (CMD) or a custom device, is a medical device designed and manufactured for the sole use of a particular patient. Examples of custom-made medical devices include auricular splints, dentures, orthodontic appliances, orthotics and prostheses.

The Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety (GPSR) is a European regulation on consumer protection. It replaces Directive 2001/95/EC on general product safety. The regulation is intended to ensure that products placed on the market in the European internal market do not endanger the health and safety of consumers through a high level of consumer protection.

References

  1. ↑ "European Authorised Representative".
  2. ↑ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0988
  3. ↑ https://www.westwoodsourcing.com/en_GB/blog/services-14/gpsr-2024-product-safety-54
  4. ↑ Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
  5. 1 2 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
  6. ↑ Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
  7. ↑ EU Authorised Representative mdrregulator.com
  8. ↑ "The 'Blue Guide' on the implementation of EU products rules 2016". Archived from the original on 2021-03-24. Retrieved 2021-04-02.

GUIDELINE FOR AUTHORISED REPRESENTATIVES

http://ec.europa.eu/health/medical-devices/files/meddev/2_5_10_ol_en.pdf

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.