INHALT

2009/455/EC: Decision No 2/2008 of 16 May 2008 of the Committee updating the legal references in the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to conformity assessment

DECISION
No 2/2008
of 16 May 2008
of the Committee updating the legal references in the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to conformity assessment
(2009/455/EC)
ANNEX
‘ANNEX 1
PRODUCT SECTORS
CHAPTER 1
MACHINERY
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Second-hand machinery
CHAPTER 2
PERSONAL PROTECTIVE EQUIPMENT
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
CHAPTER 3
TOYS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information concerning the certificate and the technical file
2.
Notification of grounds for refusal by approved bodies
CHAPTER 4
MEDICAL DEVICES
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Registration of the person responsible for placing devices on the market
2.
Labelling of medical devices
3.
Information exchange
4.
European databank
CHAPTER 5
GAS APPLIANCES AND BOILERS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(1)
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
CHAPTER 6
PRESSURE VESSELS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(1)
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Recognition of certificates and conformity marks
2.
Technical documentation
CHAPTER 7
RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
TCAM
2.
Market surveillance
3.
Regulated interfaces
4.
Interfaces offered by public telecommunications network operators
5.
Application of essential requirements
6.
Authorisation to disconnect
7.
Harmonised standards
8.
Mutual notification concerning radio communication equipment which conforms to requirements but is not intended for use in the spectrum of one of the parties
9.
Safeguard clause relating to industrial products
CHAPTER 8
EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Technical documentation
CHAPTER 9
ELECTRICAL EQUIPMENT AND ELECTROMAGNETIC COMPATIBILITY
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Technical documentation
2.
Indication of the name and address of the manufacturer
3.
Standardisation bodies
4.
Notified bodies
5.
Safeguard clause
CHAPTER 10
CONSTRUCTION PLANT AND EQUIPMENT
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Location of the manufacturer
2.
Information exchange
3.
Collection of noise data
CHAPTER 11
MEASURING INSTRUMENTS AND PRE-PACKAGES
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(1)
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Pre-packages
3.
Marking
4.
Measuring instruments covered by Directive 2004/22/EC
4.1.
Information exchange, market surveillance and administrative cooperation
4.2.
Technical documentation and declaration of conformity
CHAPTER 12
MOTOR VEHICLES
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Recognition of vehicle type-approval
3.
Vehicle type-approval safeguard clauses
Registration and entry into service
Measures related to the conformity of production
Nonconformity with the approved type
CHAPTER 13
AGRICULTURAL OR FORESTRY TRACTORS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Recognition of vehicle type-approval
3.
Vehicle type-approval safeguard clauses
Registration and entry into service
Measures related to the conformity of production
Nonconformity with the approved type
CHAPTER 14
GOOD LABORATORY PRACTICE (GLP)
Scope and coverage
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(1)
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special principles for designating conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Test facility inspections
3.
Confidentiality
4.
Cooperation
CHAPTER 15
MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION
Scope and coverage
Certification of manufacturers
Batch certification
Official batch release
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Supplementary provisions
1.
Transmission of inspection reports
2.
Inspection reports
3.
GMP Reference
4.
Nature of inspections
5.
Fees
6.
Safeguard clause for inspections
7.
Exchange of information between authorities and approximation of quality requirements
8.
Inspectors training
9.
Joint Inspections
10.
Alert system
11.
Contact points
12.
Divergence of views
CHAPTER 16
CONSTRUCTION PRODUCTS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
European harmonised standards for construction products
2.
Interpretative documents and guidance papers
3.
European Technical Approvals
4.
Information exchanges
5.
Technical documentation
6.
Person responsible for placing the products on the market and labelling