Fees Regulation To The Medical Product Law And The Regulations Issued For Its Execution

Original Language Title: Gebührenverordnung zum Medizinproduktegesetz und den zu seiner Ausführung ergangenen Rechtsverordnungen

Read the untranslated law here: http://www.gesetze-im-internet.de/bkostv-mpg/BJNR122800002.html

Fees regulation to the medical product law and the regulations issued for his execution (medical devices fees regulation BKostV-MPG) BKostV MPG Ausfertigung date: 27.03.2002 full quotation: "medical devices fees Ordinance of 27 March 2002 (BGBl. I p. 1228), most recently by article 1 of the Decree of 3 November 2014 (BGBl. I p. 1676) is has been modified" V go up. by article 4 paragraph 63 G v. 7.8.2013 I 3154 mWv 14.8.2018 stand: last amended by art. 1 V v. 3.11.2014 I in 1676 for more information on the stand number found in the menu see remarks footnote (+++ text detection from: 4.4.2002 +++) heading: name and abbreviation of idF d. art. 2 No. 1 V v. 16.2.2007 I 155 mWv 24.2.2007 input formula on the basis of § 37 para 9, 11 sentence 1 and paragraph 12 sentence 3 of the medical devices act of August 2, 1994 (BGBl. I S. 1963) , by article 1 No. 32 of the law of 13 December 2001 (BGBl. I S. 3586) recast been is, in conjunction with the 2nd section of the administrative expenses Act of 23 June 1970 (BGBl. I p. 821), ordered the Ministry of health in consultation with the Federal Ministry of Economics and technology: § 1 scope the competent federal authority charges for public accomplishments individually attributable to the medical devices act, and the regulations adopted for the implementation of this law fees and expenses in accordance with the following provisions.

Article 2 approval, extension and amendment of the registration (1) the fee for the decision 1 according to § 11 para 1 sentence 1 of the medical devices act on the approval of a medical device 2,500 up to 10,300 euros, 2. amending the registration of a medical device approved in accordance with § 11 para 1 sentence 1 of the medical devices act 100 to 1,100 euro, 3. about the renewal of the authorisation one according to § 11 para 1 sentence 2 of the medical product law temporarily approved medical device 100 to 1,100 euros.
(2) the authorization is sought at the same time for several similar medical products according to § 11 para 1 sentence 1 of the medical devices act, applies to the decision on approval for the first certified medical product paragraph 1 No. 1. For the decision on the admission of any other medical device, the fee can be reduced if the uniformity of medical devices has led to a lower inspection costs, justifying the reduction. At least, however, is a fee of 1,100 euros for any further decision on the authorisation to collect.

Article 3 classification and delineation of products the fee for a decision pursuant to article 13, paragraph 2 and 3 of the medical devices act and the classification of a medical device to the definition of medical devices to other products is 400 to 7 500 euros.

§ 4 consultation procedure (1) the fee for the opinion under the consultation according to annex II, section 4.3 or annex III section 5 in connection with Annex I paragraph 7.4 of the Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ EC No. L 169, p. 1), last by Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 (OJ EC No. L 313, p. 22) has been amended are in connection with article 4 or article 6 of the regulation concerning medical devices 1 when a new drug or a well-known drug with new purpose of 5,000 to 50,000 euro, 2. with a well-known drug used 5,000 to 20,000 euro in the conventional sense.
(2) carried out several consultation process within the same certification procedure, can each be reduced to 25 per cent of the envisaged fee the fees for the following consultations. Implementation at the same time requested several consultation proceedings relating to similar medical products, paragraph 1 shall apply to the opinion of the first medical device. The fees for the following consultations can be reduced if the uniformity of medical devices has led to a lower inspection costs, justifying the reduction. At least, however, a fee of 1,250 euros for any further consultation is to collect.

§ 5 individually attributable public services in the context of clinical trials and performance evaluation studies (1) the fee for the approval of 1 a clinical examination according to article 20, paragraph 1, of the medical product law in conjunction with Article 22a, paragraph 1 of the medical devices Act 3 000 to 9 900 euros, 2. a performance evaluation examination under section 24 of the medical product law in conjunction with article 20, paragraph 1 of the medical devices act and in conjunction with Article 22a, paragraph 1 of the medical devices Act 3 000 to 9 900 euro.
(2) for the requested review of a substantial change of 1 on a trial according to sec. 22c paragraph 2 of the medical devices act, the fee is 600 to 1 700 euros, 2. an examination of performance evaluation under section 24 of the medical product law in conjunction with section 22 c paragraph 2 of the medical devices Act 600 to 1 700 euros.
(3) If a substantial change in § 20 paragraph 1 sentence 4 number aspects referred to in 1, 5, 6 and 8 of the medical devices act is none of and is no objections expressed by the competent federal authority, the fee 100 euro.
(4) the fee is for processing other changes 1 a clinical examination referred to in section 22c paragraph 1 of the medical devices act 100 to 400 euro, 2. an examination of performance evaluation under section 24 of the medical product law in conjunction with section 22 c paragraph 1 of the medical devices act 100 to 400 euros.
(5) the fee for inspecting a proposed exemption from the permit requirement 1 for clinical trials of medical devices with low security risk according to § 20 paragraph 1 sentence 2 of the medical devices act in conjunction with section 7 paragraph 1 of the Ordinance on clinical trials of medical devices 500 to 2 000 euro, 2. for performance evaluation studies of medical devices under section 24 of the medical product law in connection with § 20 paragraph 1 sentence 2 of the medical devices act and in conjunction with article 7, paragraph 1, of the Ordinance on clinical trials of Medical devices 500 to 2 000 euro.
  (6) the fee is 25 to 250 euro for the processing of a message of a serious adverse event by the sponsor according to § 3 paragraph 6 of the medical security plan regulation.
The fees for processing the reports of serious adverse events shall not exceed 20 000 euro per clinical testing or performance assessment test as a whole.

§ 6 consultations the fee for counselling of the person responsible according to § 5 of the medical devices act, notified bodies and sponsors to section 32 of the medical devices act is 500 to 2 800 euros.

§ 7 fees in special cases (1) is 1 withdrawn a request to carry out of a paid individually attributable public performance after the beginning of the substantive editing and before completing this power or 2. rejecting an application for other reasons than lack of jurisdiction because of or 3 an administrative act withdrawn or revoked, as in accordance with § 15 paragraph 2 of the administrative costs act in force until August 14, 2013 amended charges.
(2) if the applicant to do so has given rise, number 3 is the fee for the revocation or withdrawal of a bureaucracy at least 50 euros by way of derogation from paragraph 1, a maximum fee imposed for the administrative act being revoked or withdrawn.
(3) for the complete or partial rejection of a conflict a fee up to the amount of 50 per cent of the fee laid down for the contested administrative act; This does not apply if the opposition simply has no success because the breach of a procedural or formality is irrelevant to article 45 of the Administrative Procedure Act. A fee was not intended for the contested administrative act or a fee was not charged a fee to EUR 1 500.
(4) If an opposition after the beginning of substantive editing, but before the termination is withdrawn, the fee is at least 50 euros, but not more than 75 per cent of the fee referred to in paragraph 3 (5) for the partial or complete rejection and withdrawal of an objection directed exclusively against the fees or delivery notice the fee is at least 50 euros, but no more than 10 percent of the disputed amount.
(6) If an opposition completely as inadmissible is rejected, so the fee is paragraphs 3 and 5 at least 50 euro, a maximum of 100 euros after.
(7) If an opposition is partially rejected, the fee is to reduce the paragraphs 3 and 5 depending on the share of the grant; must not fall below the minimum fee pursuant to paragraphs 3 and 5.

§ 8 other fees at following individually attributable public services performed at the request of fees are to 2 not simple written information raise 100 to 500 euro, 3. certificates for 1 scientific opinions and reports 200 to 1 000 euro, 25 euro, 4. producing copies and copies a) a basic fee of if this does not happen within the framework of the individually attributable public services according to paragraphs 1 and 2 , as well as 20 euro, b) each manufactured copy 0.5 euro, 5. the inspection of files, unless it is pending opposition proceedings 25 to 250 euro.
The applicant is to indicate the Gebührenpflichtigkeit of individually attributable public performance pursuant to sentence 1.

§ 9 fees assessment
As far as this regulation provides for fees frame rates, the calculation of the actual fee depends on section 23, paragraph 4, sentence 2 and 3 of the Federal fees law.

§ 10 fee reductions and exemptions at the request of the fees to be collected pursuant to section 2 can on application by the debtor of the fees to be reduced to a quarter of the planned fee, if the applicant one cannot expect reasonable economic benefits these fees or the use cases are rare, the target group for which the medical device is intended, is small. By collecting the fees may be waived completely, if the expected economic benefits in relation to the fees is very low.

Section 11 requires a fee increase and reduction referred to in the paragraphs 2 to 6 and 8 point 1 and 2 toll individually attributable public performance in individual cases so can exceptionally high costs, the proposed fee to be increased to double fees frame rate up to double the corresponding maximum. The fees borrowers is to hear if such increase is expected. A chargeable individually attributable public performance requires an exceptionally low expense, pursuant to sentence 1 in some cases the fee can be reduced to 50 euro.

Article 12 expenses expenses are according to the regulations of the German fees Act to refund.

§ Are 13 transitional arrangements (1) for an individually attributable public performance that was requested or started before 11 November 2014 but have not yet fully provided, to collect fees and expenses under the medical devices fees regulation in the version before 11 November 2014.
(2) for an individually attributable public performance that was made, applied for, or started before 11 November 2014 fees and expenses may be imposed under this regulation, as far as these services referring to the upcoming addition of the medical devices fees regulation a fixing of fees is expressly been reserved.

§ 14 entry into force this regulation enter into force on the day after the announcement.