Regulation on the requirements and procedure for the recognition of conformity assessment bodies

Original Language Title: Verordnung über die Anforderungen und das Verfahren für die Anerkennung von Konformitätsbewertungsstellen

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Regulation on the requirements and procedure for the recognition of conformity assessment bodies (Recognition Regulation-AnerkV)

Unofficial table of contents

AnerkV

Date of completion: 07.06.2002

Full quote:

" Recognition regulation of 7 June 2002 (BGBl. I p. 1792), most recently by Article 4 (117) of the Law of 7 August 2013 (BGBl. I p. 3154).

Status:

Last amended by Art. 4 Abs. 117 G v. 7.8.2013 I 3154

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 13.  6.2002 + + +)

Heading: IdF d. Section 22 (4) No. 1 G v. 26.2.2008 I 220 mWv 1.3.2008
The V was referred to as Article 1 (d). V v. 7.6.2002 I 1792 from the Federal Ministry of Economics and Technology in agreement with the Federal Ministries of Finance, for Transport, Building and Housing and for Work and Social Order. She's gem. Article 3, first sentence, of this V entered into force on 13 June 2002. Unofficial table of contents

Content Summary

Section 1
	General provisions
§ 1		Scope
§ 2		General requirements
Section 2
	Radio equipment and telecommunications terminal equipment
§ 3		Recognition as notified body
§ 4		Recognition as a conformity assessment body for third countries
Section 3
	Electromagnetic compatibility
§ 5		Recognition as notified body
§ 6		(dropped)
§ 7		Recognition as a conformity assessment body for third countries
Section 4
	Final provisions
§ 8		Obligation to provide notification of changes
§ 9		Erasing and revocation
§ 10		Fees and expenses
Appendix 1 (to § 4)			Agreements with a view to the recognition of conformity assessment bodies in the telecommunications sector
Appendix 2 (to § 7)			Agreements with a view to the recognition of conformity assessment bodies in the electromagnetic compatibility sector
Appendix 3 (to § 10)			Fees and expenses for the recognition of notified bodies and conformity assessment bodies for third countries

Section 1
General provisions

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§ 1 Scope

This Regulation lays down the requirements and the procedure

1.

with regard to radio equipment and telecommunications terminal equipment for

a): the recognition of notified bodies and
b): the recognition of conformity assessment bodies for third countries in the framework of the agreements between the European Community and the third countries referred to in Annex 1 to this Regulation, and

2.

with regard to the electromagnetic compatibility of operating equipment for

a): the recognition of notified bodies and
b): the recognition of conformity assessment bodies for third countries within the framework of the agreements between the European Community and the third countries referred to in Annex 2 to this Regulation.

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§ 2 General requirements

An applicant may be recognised as a notified body or conformity assessment body for third countries only if:

1.: it has the staff necessary for the operation of the body and the technical equipment necessary to carry out the tasks assigned to it properly,
2.: they have the necessary technical competence and professional integrity to carry out the tasks assigned to them in carrying out the relevant tasks,
3.: they have the necessary independence and personal reliability, including the necessary secrecy, in the performance of their duties in the performance of their duties,
4.: ensure that the necessary organisation and the necessary financial resources are available to it to carry out the tasks associated with the designation,
5.: he has a documented quality management system which complies with the recognised rules of technology,
6.: it undertakes to grant subcontracting for exams only if the consent of the contracting authority is in place and the subcontractor has a recognition corresponding to that regulation or the Federal Network Agency for Electricity, Gas, telecommunications, postal services and railways shall certify the qualifications of the subcontractor as equivalent to the qualifications of a body recognised by it;
7.: the Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railways shall at all times provide information on its activities by written declaration.

Section 2
Radio equipment and telecommunications terminal equipment

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§ 3 Recognition as a notified body

(1) With recognition as a notified body within the meaning of the law on radio equipment and telecommunications terminal equipment, a natural or legal person or a legally competent partnership shall be empowered to carry out the tasks of: Conformity assessment and the evaluation and monitoring of quality management systems in accordance with at least one of Annexes III to V to Directive 1999 /5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and Telecommunications terminal equipment and the mutual recognition of their conformity (OJ L 327, 30.4.2004, EC No 10). (2) The Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railways (Bundesnetzagentur für Electricity, Gas, Telecommunications, Post and Railways) is responsible for the implementation of the recognition procedure. The recognition as a notified body must be submitted in writing to the Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railways. The area for which recognition is requested shall be indicated. The application documents of the Authority shall be used. The notified body must provide evidence of a documented quality management system corresponding to the recognised rules of technology. The fulfilment of the requirements listed in § 2 and contained in Annex VI to Directive 1999 /5/EC shall be stated. The notified body must provide evidence of the termination of a liability insurance cover covering its risks. (3) The Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railways is entitled to carry out the necessary documents for the examination. and to carry out an examination with the applicant. The Authority shall decide on the basis of the application by written notice. (4) The recognition as a notified body shall be limited to a limited period. (5) The recognition as a notified body shall be notified to the European Commission via the Federal Ministry of Economic Affairs and technology. The notified body shall be assigned a identification number. (6) The Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railways shall regularly check whether the notified bodies continue to comply with the requirements. Unofficial table of contents

Section 4 Recognition as a conformity assessment body for third countries

(1) The recognition as a conformity assessment body for third countries in the framework of the agreements between the European Community and the third countries referred to in Appendix 1 to this Regulation is a natural or legal basis for (2) to carry out the task of carrying out the conformity assessment in the telecommunications sector for the third country or third countries referred to in the relevant agreement. The procedure for recognition as a conformity assessment body is the Federal Agency for Electricity, Gas, Telecommunications, Post and Railways in charge of the Federal Foreign Office. § 3 (2) sentence 2 to 5, para. 3, 4, 5 sentence 1 and para. 6 shall apply mutatily. The fulfilment of the requirements relating to the sectoral annex to telecommunications listed in § 2 and contained in the respective agreements shall be stated.

Section 3
Electromagnetic compatibility

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Section 5 Recognition as a notified body

(1) With recognition as a notified body within the meaning of the law on the electromagnetic compatibility of equipment, a natural or legal person or a legally competent partnership shall be empowered to perform the tasks of the (2) The Federal Network Agency for Electricity, Gas, shall be responsible for the implementation of the Accreditation Procedure as notified body. telecommunications, postal services and railways. § 3 (2) sentences 2 to 5 and 7 and para. 3 to 6 shall apply accordingly. The fulfilment of the requirements listed in § 2 and contained in § 10 paragraph 1 of the Act on the electromagnetic compatibility of operating resources must be stated. The application shall, in particular, be accompanied by a declaration that the issuing of a certificate of conduct for the head or senior staff of the applicant for submission to an authority pursuant to Section 30 (5) of the Federal Central Register Act shall be submitted to the applicant in the Version of the notice of 21 September 1984 (BGBl. 1229, 1985 I p. 195), which was last amended by Article 4 of the Law of 21 August 2007 (BGBl I). 2118), and information from the Register of Trade Central Register for submission to an authority pursuant to Section 150 (5) of the Industrial Code as amended by the Notice of 22 February 1999 (BGBl. 202), as last amended by Article 9 of the Law of 21 December 2007 (BGBl). 3089), it has been requested. Unofficial table of contents

§ 6

(dropped) Unofficial table of contents

Section 7 Recognition as a conformity assessment body for third countries

(1) The recognition as a conformity assessment body for third countries within the framework of the agreements between the European Community and the third countries referred to in Annex 2 to this Regulation is a natural or legal one (2) To carry out the procedure, to carry out the tasks of conformity assessment with regard to the electromagnetic compatibility of third countries within the framework of the relevant agreement. the recognition as a conformity assessment body is the Federal Network Agency for Electricity, Gas, Telecommunications, Post Office and Railways. § 3 (2) sentence 2 to 5, para. 3, 4, 5 sentence 1 and para. 6 shall apply mutatily. The fulfilment of the requirements of the sectoral annex relating to electromagnetic compatibility listed in § 2 and contained in the respective agreements shall be stated.

Section 4
Final provisions

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§ 8 obligation to provide notification of amendments

If amendments of a technical, organisational or personal nature arise at one of the posts within the meaning of § § 3 to 7, which could affect the conditions for recognition, they shall immediately inform the Federal Network Agency for the purpose of Electricity, gas, telecommunications, postal services and railways. Unofficial table of contents

§ 9 Erasing and Revocation

(1) The appointment or recognition as a notified body or conformity assessment body for third countries shall cease with the cessation of the establishment of the body. The Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railways shall be notified in writing without delay. (2) The recognition shall be revoked if:

1.: the body repeats the obligations of the Regulation and does not comply, in spite of the request, or
2.: the body so requests.

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§ 10 Fees and charges

Charges and outlays under Annex 3 to this Regulation shall be charged for individually attributable public services pursuant to the above-mentioned regulations. For the revocation or withdrawal of an administrative act, the rejection of an application for an individual attributable public service, and in the cases of withdrawal of an application for the acceptance of an individually attributable Public service charges are levied in accordance with § 23 (5) sentence 1 and 2 of the Federal Law on Fees. Unofficial table of contents

Appendix 1 (to § 4)
Agreements with a view to the recognition of conformity assessment bodies in the telecommunications sector

Source of the original text: BGBl. I 2002, 1795 Council Decision of 18 June 1998 concerning the conclusion of the Agreement between the European Community and Australia on the mutual recognition of conformity assessment, certification and labelling (98/508/EC) 1. EC No L 229 p. 1)
Council Decision of 18 June 1998 concerning the conclusion of the Agreement between the European Community and New Zealand on the mutual recognition of conformity assessment (98/509/EC) (OJ L 136, 31.7.1998, p. 1). EC No L 229 p. 61)
Council Decision of 20 June 1998 on the conclusion of the Agreement between the European Community and Canada on mutual recognition (98/566/EC) (OJ L 136, 31.7.1998, p. 1). EC No L 280 p. 1)
Council Decision of 22 June 1998 concerning the conclusion of the Agreement between the European Community and the United States of America on mutual recognition (1999/78/EC) (OJ L 139, 30.4.1998, p. EC No L 31 p. 1)
Council Decision of 27 September 2001 on the conclusion of the Agreement between the European Community and Japan on mutual recognition (2001/747/EC) (OJ L 139, 30.4.2001, p. EC No L 284 p. 1) Unofficial table of contents

Appendix 2 (to § 7)
Agreements with a view to the recognition of conformity assessment bodies in the electromagnetic compatibility sector

Appendix 3 (to § 10)
Fees and expenses for the recognition of notified bodies and conformity assessment bodies for third countries

(Fundstelle des Originaltextes: BGBl. I 2002, 1796-1798;
with regard to of the individual amendments, cf. Footnote)

¹⁾
1. Fees and charges for the recognition of designated Stellten pursuant to § 3 Fee Payout Fee Fee in Euro

1.1	Administrative processing of the application for recognition as notified body in accordance with the law on radio equipment and telecommunications terminal equipment; verification of formal requirements	1 000
1.1	This position shall also be due on extension of the area of the notified body.	1 000
1.2 ²⁾	Administrative implementation of the recognition procedure as notified body; verification of formal requirements, including implementation of the assessment ³⁾	5 000
1.3	Periodic review in accordance with § 3 (6)	2 000
1.4	Issuing a certificate	250
1.5	Application for auditing by surveyors, including preparation, evaluation and follow-up per person and day ⁴⁾	810
1.6	Request-related verification of requirements	from 1 000 to 2 000

1): In the event of a disproportionate administrative burden caused by the applicant, the recognised authority may levy surcharges of up to 50 per cent of the number of charge numbers 1.1 and 1.2.
2): Position 1.2 is also subject to the additional position 1.1.
3): In the case of additional tests according to the basic requirements laid down in § 3 (1) (1) of the Act on radio equipment and telecommunications terminal equipment, the fee can be increased in accordance with position 1.2 and up to 50 of the hundred. If the area is extended during the current period of recognition, the fee can be reduced to 25 per cent, according to the position 1.2.
4): The reimbursement of travel expenses incurred as well as other expenses shall take place in accordance with § 10 of the Administrative Costs Act in the version valid until 14 August 2013, provided that these costs are not directly accepted by the applicant.

⁵⁾
2. Fees for the recognition of conformity assessment bodies for third countries according to § 4 Fee Payout Fee Fee in Euro

2.1	Administrative processing of the application for recognition as a conformity assessment body for a third country in the telecommunications sector; verification of formal requirements	500
2.1	This position shall also be due in the case of extension of the area of conformity assessment body.	500
2.2	Implementation of the evaluation and recognition procedure
2.2.1 ⁶⁾	Administrative implementation of an evaluation procedure for recognition as a conformity assessment body for a third country in the telecommunications sector; verification of formal requirements and implementation of the assessment, including: Assessment of the basic general requirements (such as those B. in the DIN EN 45000er series)	5 000
2.2.2 ⁷⁾	Administrative implementation of an evaluation procedure for recognition as a conformity assessment body for a third country in the telecommunications sector; verification of the formal requirements and the implementation of the assessment on the basis of the Terms and conditions of the third country agreement without evaluation of the basic general requirements (such as those B. in the DIN EN 45000er series)	2 500
2.3	Periodic review pursuant to § 4 (2) sentence 2 and 3	1 000
2.4	Issuing a certificate	125
2.5	Application for auditing by external experts, including preparation, evaluation and follow-up per person and day ⁸⁾	810

5): In the event of a disproportionate administrative burden caused by the applicant, the recognised authority may levy surcharges of up to 50 per cent of the number of charge numbers 2.1, 2.2.1 and 2.2.2.
6): Position 2.2.1 is also subject to the additional position 2.1.
7): Position 2.2.2 is also subject to the additional position 2.1.
8): The reimbursement of travel expenses incurred as well as other expenses shall take place in accordance with § 10 of the Administrative Costs Act in the version valid until 14 August 2013, provided that these costs are not directly accepted by the applicant.

⁹⁾
3. Charges for the recognition of notified bodies according to § 5 Fee Payout Fee Fee in Euro

3.1	Administrative processing of the application for recognition as notified body in accordance with the law on the electromagnetic compatibility of equipment; verification of formal requirements This position shall also be due on extension of the area of the notified body.	1 000
3.2 ¹⁰⁾	Administrative implementation of the recognition procedure as notified body; verification of formal requirements, including implementation of the assessment ¹¹⁾	5 000
3.3	Periodic review pursuant to § 5 (2) sentence 2 and 3	2 000
3.4	Issuing a certificate	250
3.5	Application for auditing by surveyors, including preparation, evaluation and follow-up per person and day ¹²⁾	810
3.6	Request-related verification of requirements	from 1 000 to 2 000
3.7	Transfer to a notified body of a recognition by a competent body in accordance with Directive 89 /336/EEC in accordance with Directive 2004 /108/EC	1 000

9): In the event of a disproportionate administrative burden caused by the applicant, the recognised authority may levy surcharges up to 50 per cent of the number of charge numbers 3.1 and 3.2.
10): Position 3.1 is also subject to the additional position 3.1.
11): If the area is extended during the current recognition period, the fee can be reduced to 25 per cent.
12): The reimbursement of travel expenses incurred as well as other expenses shall take place in accordance with § 10 of the Administrative Costs Act in the version valid until 14 August 2013, provided that these costs are not directly accepted by the applicant.

4. (dropped)

13): (dropped)
14): (dropped)
15): (dropped)

¹⁶⁾
5. Fees for the recognition of conformity assessment bodies for third countries according to § 7 Fee Payout Fee Fee in Euro

5.1	Administrative processing of the application for recognition as a conformity assessment body for a third country in the electromagnetic compatibility sector;	500
5.1	Verification of formal requirements This position is also due on extension of the area of the conformity assessment body.	500
5.2	Implementation of the evaluation and recognition procedure
5.2.1 ¹⁷⁾	Administrative implementation of an evaluation procedure for recognition as a conformity assessment body for a third country in the field of electromagnetic compatibility; review of the formal requirements and implementation of the assessment on the basis of the conditions of the third country agreement, including the assessment of the basic general requirements (such as those relating to: B. in the DIN EN 45000er series)	5 000
5.2.2 ¹⁸⁾	Administrative implementation of an evaluation procedure for recognition as a conformity assessment body for a third country in the field of electromagnetic compatibility; review of the formal requirements and implementation of the assessment on the basis of the conditions of the third country agreement, without evaluation of the basic general requirements (such as those relating to: B. in the DIN EN 45000er series)	2 500
5.3	Periodic review in accordance with § 7 para. 2 sentence 2 and 3	1 000
5.4	Issuing a certificate	125
5.5	Application for auditing by external experts, including preparation, evaluation and follow-up per person and day ¹⁹⁾	810

16): In the event of a disproportionate administrative burden caused by the applicant, the recognised authority may levy surcharges of up to 50 per cent of the number of charge numbers 5.1, 5.2.1 and 5.2.2.
17): Position 5.2.1 is also subject to the additional position 5.1.
18): Position 5.2.2 is also subject to the additional position 5.1.
19): The reimbursement of travel expenses incurred as well as other expenses shall take place in accordance with § 10 of the Administrative Costs Act in the version valid until 14 August 2013, provided that these costs are not directly accepted by the applicant.