Toll Ordinance on the Medical Devices Act and the legal regulations issued in its implementation (Medical Devices Fee Ordinance-BKostV-MPG)

Unofficial table of contents

BKostV-MPG

Date of completion: 27.03.2002

Full quote:

" Medical Devices Fee Ordinance of 27 March 2002 (BGBl. 1228), as last amended by Article 1 of the Regulation of 3 November 2014 (BGBl I). 1676).

V up. By Art. 4 (63) G v. 7.8.2013 I 3154 mWv 14.8.2018
Status:	Last amended by Art. 1 V v. 3.11.2014 I 1676

For more details, please refer to the menu under Notes

Footnote

(+ + + Proof of text: 4.4.2002 + + +) 

  

Heading: Label u. Short term idF d. Art. 2 No. 1 V v. 16.2.2007 I 155 mWv 24.2.2007 Unofficial table of contents

Input formula

On the basis of § 37 (9), 11 sentence 1 and (12) sentence 3 of the Medical Devices Act of 2 August 1994 (BGBl. I p. 1963), as defined by Article 1 (32) of the Law of 13 December 2001 (BGBl. 3586), in conjunction with the second section of the Administrative Costing Act of 23 June 1970 (BGBl I). 821), the Federal Ministry of Health, in agreement with the Federal Ministry of Economics and Technology, is responsible for: Unofficial table of contents

§ 1 Scope

The competent authority of the Federal Supreme Court shall collect fees and deposits for its individual public services under the Medical Devices Act and the legal regulations issued for the implementation of this Act, in accordance with the following conditions: Regulations. Unofficial table of contents

§ 2 Admission, renewal and amendment of the authorisation

(1) The fee shall be for the decision

1.	According to § 11 paragraph 1 sentence 1 of the Medical Devices Act on the approval of a medical device	2,500 to 10,300 Euro,
2.	on the amendment of the authorisation of a medical product approved in accordance with § 11 para. 1 sentence 1 of the Medical Devices Act	100 to 1,100 Euro,
3.	on the renewal of the authorisation of a medical device approved for a limited period in accordance with § 11 paragraph 1 sentence 2 of the Medical Devices Act	100 to 1,100 Euro.

(2) If the authorisation pursuant to Section 11 (1) sentence 1 of the Medical Devices Act is applied for at the same time for several similar medical devices, the decision on the authorisation for the first certified medical device shall apply to paragraph 1. For the decision on the approval of any other medical device, the fee may be reduced if the similarity of the medical devices has resulted in a lower testing effort, which justifies the reduction. At least, however, a fee of 1,100 euros is to be levied for each further decision on admission. Unofficial table of contents

§ 3 Classification and delimitation of products

The fee for a decision pursuant to § 13 (2) and (3) of the Medical Devices Act for the classification of a medical device and for the delimitation of medical devices to other products is 400 to 7 500 Euro. Unofficial table of contents

§ 4 Consultation procedure

(1) The fee for the opinion in the context of the consultation referred to in Annex II, point 4.3 or Annex III, point 5, in conjunction with Annex I, point 7.4 of Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 378, 27.11.1993, p. EC No 1), as last amended by Directive 2000 /70/EC of the European Parliament and of the Council of 16 November 2000 (OJ L 169, 30.7.2000, p. EC No 22), in conjunction with Section 4 or Article 6 of the Medical Devices Regulation

1.	in the case of a new medicinal substance or of a known medicinal substance with a new purpose	5,000 to 50,000 euros,
2.	in the case of a known medicinal substance used in the conventional sense	5,000 to 20,000 euros.

(2) If several consultation procedures are carried out within the same certification procedure, the fees for the following consultations may be reduced to 25 per cent of the intended fee. Where the application of a number of consultation procedures relating to similar medical devices is requested at the same time, the opinion shall apply to the first medical device (1). The fees for the following consultations may be reduced if the similarity of the medical devices has resulted in a lower testing effort which justifies the concession. However, at least a fee of € 1,250 is to be charged for each further consultation. Unofficial table of contents

§ 5 Individually attributable
Public services in the context of clinical
Examinations and performance assessment tests

(1) The fee shall be for the approval

1.	a clinical trial in accordance with § 20 (1) of the Medical Devices Act, in conjunction with Section 22a (1) of the Medical Devices Act (Medical Devices Act)	3 000 to 9 900 Euro,
2.	A performance assessment test in accordance with § 24 of the Medical Devices Act in conjunction with Section 20 (1) of the Medical Devices Act and in conjunction with § 22a (1) of the Medical Devices Act	3 000 to 9 900 Euro.

(2) The fee shall be for the assessment of a substantial change requested

1.	at a clinical trial in accordance with § 22c (2) of the Medical Devices Act	600 to 1 700 Euro,
2.	on a performance assessment test in accordance with § 24 of the Medical Devices Act in conjunction with Section 22c (2) of the Medical Devices Act	600 to 1 700 Euro.

(3) If a substantial change does not affect any of the aspects mentioned in § 20 (1) sentence 4, points 1, 5, 6 and 8 of the Medical Devices Act and no objections are expressed by the competent federal authority, the fee is 100 euros. (4) The fee shall be for the processing of any other change

1.	at a clinical trial in accordance with § 22c (1) of the Medical Devices Act	100 to 400 Euro,
2.	on a performance assessment test in accordance with § 24 of the Medical Devices Act in conjunction with Section 22c (1) of the Medical Devices Act	100 to 400 euros.

(5) The fee shall be for the examination of a request for exemption from the permit requirement

1.	for clinical testing of medical devices with a low safety risk in accordance with § 20 paragraph 1 sentence 2 of the Medical Devices Act in conjunction with Section 7 (1) of the Regulation on clinical trials of medical devices	500 to 2 000 Euro,
2.	for performance assessment tests of medical devices according to § 24 of the Medical Devices Act in conjunction with § 20 paragraph 1 sentence 2 of the Medical Devices Act and in conjunction with § 7 paragraph 1 of the Ordinance on Clinical Trials of Medical Devices	500 to 2 000 euros.

(6) The fee shall be for the processing of a notification of a serious adverse event by the sponsor pursuant to § 3 paragraph 6 of the Medical Devices-Safety Planning Regulation	25 to 250 euros.
The fees for processing the reports of serious adverse events may not exceed a total of EUR 20 000 per clinical trial or performance assessment test.

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Section 6 deliberations

The fee for the advice of the person responsible according to § 5 of the Medical Devices Act, of the notified bodies and of sponsors according to § 32 of the Medical Devices Act amounts to 500 to 2 800 euros. Unofficial table of contents

§ 7 Fees in special cases

(1)

1.

a request for the reception of a chargeable, individually attributable public service after the commencement of the factual processing and before the end of that service, or

2.

a request for reasons other than those rejected for lack of competence, or

3.

withdraw or revoke an administrative act,

fees shall be levied in accordance with the provisions of Section 15 (2) of the Administrative Costing Act in the version valid until 14 August 2013. (2) Notwithstanding the provisions of paragraph 1 (3), if the applicant has given rise to this, the fee shall be for the Revocation or withdrawal of an administrative act at least 50 euros, at most the fee fixed for the revoked or withdrawn administrative act. (3) For the complete or partial refusal of an objection, a fee will be charged. up to 50 per cent of the fee fixed for the administrative act under appeal , this shall not apply if the objection is not successful only because the infringement of a procedural or formal provision in accordance with Section 45 of the Administrative Procedure Act is inconformable. If a fee was not provided for the contested administrative act, or if a fee was not charged, a fee of up to EUR 1 500 is charged. (4) If an objection is made after the commencement of the factual processing, but before the end of the fee, the fee will be charged. , the fee shall be at least EUR 50, but not more than 75% of the fee referred to in paragraph 3. (5) For the partial or complete rejection and the withdrawal of an exclusively anti-charge or outsourcing decision, The fee shall be at least 50 euros, but not more than 10 percent of the dispute. (6) If a contradiction is completely rejected as inadmissible, the fee referred to in paragraphs 3 and 5 shall be at least EUR 50, not more than EUR 100. (7) If a contradiction is partially rejected, the fee shall be referred to in paragraphs 3 and 5. 5 shall not fall below the minimum fee referred to in paragraphs 3 and 5, in accordance with the share of the taking-up of the event. Unofficial table of contents

§ 8 Other charges

In the case of the following individually attributable public services, which are made on request, fees must be charged for

1.	scientific opinions and opinions		200 to 1 000 Euro,
2.	Non-simple written information		100 to 500 Euro,
3.	Certificates		25 Euro,
4.	the production of copies and copies
	a)	a basic fee, provided that this does not take place within the framework of the individually attributable public services referred to in points 1 and 2, and	20 Euro,
	b)	any copy made	0.5 Euro,
5.	the inspection in files, unless there is an opposition proceedings pending		25 to 250 euros.

The applicant shall be informed of the fee requirements of the individually attributable public service as set out in the first sentence. Unofficial table of contents

§ 9 Fee measurement

To the extent that this Regulation provides for charging framework rates, the calculation of the specific fee shall be determined in accordance with the second sentence of Article 23 (4) and (3) of the Federal Law on Fees. Unofficial table of contents

§ 10 Fee reduction and exemption on request

The fees to be charged pursuant to § 2 may, at the request of the fee debtor, be reduced to a quarter of the intended fee if the applicant cannot reasonably expect an economic benefit to those charges, or the fees payable may be Use cases are rare, or the target group for which the medical device is intended is small. The levying of charges may be quite apart if the economic benefits to be expected are particularly low in relation to the charges. Unofficial table of contents

§ 11 Fee increase and reduction

Where, in individual cases, an individually attributable public service subject to charges under Articles 2 to 6 and 8 (1) and (2) requires exceptionally high expenditure, the intended fee may be increased to double the amount of a fee, in the case of a public service which is subject to an individual fee. Fee-frame rate up to double the maximum rate. The fee debtor shall be heard if such an increase is to be expected. If a chargeable individual public service according to sentence 1 requires an exceptionally low cost in the individual case, the fee may be reduced to 50 euros. Unofficial table of contents

§ 12 Deposits

Deposits are to be reimbursed in accordance with the provisions of the Federal Law on Fees. Unofficial table of contents

Section 13 Transitional Regulation

(1) Charges and deposits are in accordance with the Medical Devices Fee Ordinance, as amended, for an individually attributable public service, which has been requested or started before November 11, 2014, but has not yet been fully provided. November 11, 2014. (2) Fees and deposits may be levied under this Regulation for an individually attributable public service, which has been made, requested or commenced before 11 November 2014, to the extent that: Benefits, recalling the forthcoming addition to the Medical products-Fee regulation has been expressly reserved for a fee fixing. Unofficial table of contents

Section 14 Entry into force

This Regulation shall enter into force on the day following the date of delivery.