La nueva Guía Azul, de fecha 04 2014

Una nueva Guía Azul fue publicado por la Comisión Europea. Ahora sustituye a la antigua Guía Azul que fue publicado en 2000.

Esta guía ha sido publicada bajo la siguiente referencia: Ref. Ares (2014) 1025242 - 04/02/2014

El contenido de esta guía está disponible en Inglés, francés y alemán, y aborda los siguientes puntos:

La "Guía Azul" sobre la aplicación de la normativa de la UE sobre los productos en 2014

Puedes descargar la nueva guía azul desde este enlace

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The content of this new blue guide is :

 

1. REGULATING THE FREE MOVEMENT OF GOODS.

1.1. A historical perspective

1.1.1. The ‘Old Approach’

1.1.2. Mutual Recognition.

1.1.3. The ‘New Approach’ and the ‘Global Approach’

1.2. The ‘New Legislative Framework’

1.2.1. The concept.

1.2.2. The legal nature of the NLF acts and their relationship to other EU legislation

1.2.3. How the system fits together

1.3. The General Product Safety Directive.

1.4. The legislation on product liability

1.5. Scope of the Guide

2. WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY?

2.1. Product coverage

2.2. Making available.

2.3. Placing on the market

2.4. Products imported from countries outside the EU

2.5. Putting into service or use (and installation)

2.6. Simultaneous application of Union harmonisation acts.

2.7. Intended use / misuse

2.8. Geographical application (EEA EFTA states, Overseas Countries and Territories (OCTs), Turkey).

2.8.1. Member States and Overseas countries and territories.

2.8.2. EEA EFTA states.

2.8.3. Monaco, San Marino and Andorra.

2.8.4. Turkey

2.9. Transitional periods in the case of new or revised EU rules

3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS

3.1. Manufacturer

3.2. Authorised Representative

3.3. Importer.

3.4. Distributor.

3.5. End-user

4. PRODUCT REQUIREMENTS

4.1. Essential product requirements.

4.1.1. Definition of essential requirements.

4.1.2. Conformity with the essential requirements: Harmonised standards

4.1.3. Conformity with the essential requirements: Other possibilities.

4.2. Traceability requirements

4.2.1. Why does traceability matter?

4.2.2. Traceability provisions.

4.3. Technical documentation.

4.4. EU Declaration of conformity

4.5. Marking requirements

4.5.1. CE marking.

4.5.2. Other mandatory markings

5. CONFORMITY ASSESSMENT.

5.1. Modules for conformity assessment.

5.1.1. What is conformity assessment?.

5.1.2. The modular structure of conformity assessment in Union harmonisation legislation.

5.1.3. Actors in conformity assessment - Positioning of conformity assessment in the supply chain.

5.1.4. Modules and their variants.

5.1.5. One- and two-module procedures - Procedures based on type (EU-type examination).

5.1.6. Modules based on quality assurance

5.1.7. Overview of modules.

5.1.8. Overview of procedures

5.1.9. Rationale for selecting the appropriate modules.

5.2. Conformity assessment bodies

5.2.1. Conformity assessment bodies and notified bodies.

5.2.2. Roles and responsibilities

5.2.3. Competences of Notified bodies

5.2.4. Coordination between notified bodies

5.2.5. Subcontracting by notified bodies.

5.2.6. Accredited in-house bodies.

5.2.7. Recognised Third-Party Organisations (RTPOs) and User Inspectorates.

5.3. Notification.

5.3.1. Notifying authorities.

5.3.2. Notification process.

5.3.3. Publication by the Commission – the NANDO web site

5.3.4. Suspension – withdrawal – appeal.

6. ACCREDITATION

6.1. Why accreditation?

6.2. What is accreditation?

6.3. Scope of Accreditation.

6.4. Accreditation according to Regulation (EC) No 765/2008

6.4.1. National accreditation bodies

6.4.2. Non-competition and non-commerciality of national accreditation bodies

6.5. The European accreditation infrastructure

6.5.1. Sectoral accreditation schemes.

6.5.2. Peer evaluation

6.5.3. Presumption of conformity for national accreditation bodies

6.5.4. EA’s role in supporting and harmonising accreditation practice across Europe

6.6. Cross-border accreditation

6.7. Accreditation in the international context

6.7.1. Cooperation between accreditation bodies.

6.7.2. The impact on trade relations in the field of conformity assessment between the EU and Third Countries.

7. MARKET SURVEILLANCE.

7.1. Why do we need market surveillance?.

7.2. Market Surveillance activities

7.3. Member States responsibilities

7.3.1. National infrastructures.

7.3.2. National Market Surveillance Programmes (NMSP)

7.3.3. Control of products from third countries by customs: national organisation and coordination

7.3.4. Public information

7.3.5. Market surveillance procedures (including safeguard mechanisms)

7.3.6. Corrective measures – bans – withdrawals-recalls

7.3.7. Sanctions.

7.4. Safeguard mechanisms for Member States.

7.4.1. Objective and place of safeguard mechanisms in market surveillance process

7.4.2. The application of safeguard mechanisms step by step.

7.5. Cooperation and exchange of information between the Member States and the European Commission

7.5.1. Cooperation among Member States

7.5.2. RAPEX

7.5.3. ICSMS

7.5.4. Medical devices: vigilance system

8. FREE MOVEMENT OF PRODUCTS WITHIN THE EU

8.1. Free movement clause

8.2. Limits and restrictions.

9. INTERNATIONAL ASPECTS OF THE EU LEGISLATION ON PRODUCTS.

9.1. Agreements on Conformity Assessment and Acceptance (ACAAs)

9.2. Mutual recognition agreements (MRAs).

9.2.1. Main characteristics.

9.2.2. EU-Swiss MRA.

9.2.3. EEA EFTA States: Mutual recognition agreements and Agreements on Conformity Assessment and Acceptance

10. ANNEXES.

10.1. Annex 1 - EU legislation referred to in the Guide (non-exhaustive list).103

10.2. Annex 2 - Additional guidance documents.107

10.3. Annex 3 - Useful web addresses

10.4. Annex 4 - Conformity assessment procedures (modules from Decision No 768/2008/EC

10.5. Annex 5 - Relation between ISO 9000 and modules requiring a quality assurance system.

10.6. Annex 6 - Using Harmonised Standards to assess the competence of Conformity Assessment Bodies

10.7. Annex 7 - Frequently Asked Questions on CE marking