143. Federal Law to amend the Medical Devices Act and the Medicines Act

The National Council has decided:

Article 1

Amendment of the Medical Devices Act

The Medical Devices Act-MPG, BGBl. No. 657/1996, as last amended by the Federal Law BGBl. I n ° 77/2008 and the Federal Ministries Act of 2009, Federal Law Gazette (BGBl). I No 3, shall be amended as follows:

1. In § 2 (1) the introduction words are:

"medical devices" means any instrument, apparatus, apparatus, software, material or other object used individually or in combination, including those used by the manufacturer specifically for use in diagnostic or therapeutic applications. The use of software intended for the proper functioning of the medical device intended for use by the manufacturer for human use for the following purposes: "

2. According to Article 2 (1), the following paragraphs 1a to 1c are inserted:

"(1a)" Subcategory of medical devices " is a group of medical devices intended to be used in the same areas or equipped with the same technologies.

(1b) "Generic Product Group" means a group of medical devices with the same or similar uses or with technological commonalities, so that they are classified in general, without taking into account specific characteristics .

(1c) "one-time product" means a medical device intended for one-off use on a single person. "

Article 2 (5c) reads as follows:

"(5c)" medicinal product with a derivative of human blood " means a medical device as defined in Directive 90 /385/EEC or Directive 93 /42/EEC, which contains, as a constituent, a substance which is used separately as a component of a medicinal product, or Medicinal products derived from human blood or human plasma within the meaning of Article 1 (10) of Directive 2001 /83/EC, which may, in addition to the medical device, have an effect on the human body. The substance mentioned is hereinafter referred to as the "human blood derivative".

4. In Section 2 (7) and (8) as well as in the introduction words of section 33 (1), the word order shall be "civil society of commercial law or registered labour force" is deleted.

Section 2 (8a) reads as follows:

"(8a)" Plenipotentiary " means the natural or legal person established in the European Economic Area (EEA), which has been expressly designated by the manufacturer, with regard to his obligations under this Federal Act, in to act on its behalf and to be contacted by the authorities and bodies in the EEA in this regard. Where a manufacturer who places a medical device on his own behalf does not have a registered office in a Contracting Party of the EEA, he must, in writing for at least all medical devices of the same model, provide a single responsible representative in the EEA. "

6. In § 3 (2) and (2a) the expression shall be "subjects" by the expression "test participants", in Section 3 (9), the word order shall be "the test persons participating in it" through the phrase "the test participant" and in Section 3 (15), the phrase "in the case of an experimental person involved in a clinical trial" through the phrase "in the case of a test participant included in a clinical trial" In accordance with § 41 (2) and (4), § 43, § 50 (4), § 59 (3), § 60 (1) and (3), § 64 (4) and § 66, the term " "subjects" by the expression "Review Participants" ; in § 3 (8), § 41 (2) and § 63 (4), the expression shall be replaced by the following expression: "experimental person" by the expression "Review Participants" ; in Section 41 (1), the word order shall be replaced by "the test person" through the phrase "the test participant" ; in Section 47 (1), the word order shall be replaced by "the test person by the measures taken on it" through the phrase "of the examination participant by the measures carried out on him" , in Section 47 (2), the word order shall be "the test person" through the phrase "the test participant" and in Section 47 (3), the phrase "The subject and in the cases of § 51 her" through the phrase "The examination subject and in the cases of § 51" ; in Section 63 (4), the phrase shall be replaced by "the test person" through the phrase "the test participant" replaced.

7. In accordance with Section 3 (2a), the following paragraph 2b is inserted:

"(2b)" Clinical data " means security or performance data resulting from the use of a medical device and derived from the following sources:

1.		clinical trials of the medicinal product concerned, or
2.		clinical trials or other studies in the scientific literature on a similar medical product, the similarity of which can be demonstrated with the medical device concerned; or
3.		published or unpublished reports on other clinical experiences either with the medical device in question or a similar medical device whose similarity can be demonstrated with the medical device concerned. "

8. § 3 (4) reads:

"(4)" Clinical examiner "shall be the physician or dentist responsible for carrying out the clinical trial, and in particular for the well-being of the examination participant."

Section 3 (5) reads as follows:

(5) "Sponsor" means any natural or legal person who assumes the responsibility for the planning, initiation, implementation and financing of a clinical trial. The sponsor shall be established in a Contracting Party of the EEA. The clinical examiner shall assume the duties and responsibilities of the sponsor in addition, if he carries out a clinical trial independently of the manufacturer of the medical product and in full ownership. "

10. § 4 Abs.1 Z 1 reads:

" 1.		Medicinal products within the meaning of the Medicines Act (AMG), BGBl. No 185/1983, in accordance with § 5; the decision as to whether a product falls under the AMG or under this federal law shall, in particular, take place on the basis of the main mode of operation of the product, "

11. § 4 (1) Z 4 reads:

" 4.		organs, tissues or cells of human origin, as well as products containing tissues or cells of human origin, or obtained from such tissues or cells, unless they are in vitro diagnostic medical devices or medical devices in accordance with Article 2 (5c), "

12. In § 4 (1), the Z 6 is deleted; the previous Z 7 is given the name "6" .

13. In accordance with § 4, the following § 4a is inserted:

" § 4a. (1) Medical devices in accordance with Directive 93 /42/EEC, which are also intended for use by the manufacturer in accordance with the provisions relating to personal protective equipment of Directive 89 /686/EEC, shall also be subject to the provisions of this Federal Law.

(2) Medical devices according to Directives 90 /385/EEC and 93 /42/EEC, which are also machinery within the meaning of Article 2 (a) of Directive 2006 /42/EC, are subject to the provisions of this Federal Law. "

14. According to § 5, the following § § 5a and 5b together with the headings are inserted:

" Detention procedure

§ 5a. (1) The Federal Office for Health Security has, at the request of a manufacturer or its authorised representative, to determine, in the event of the intended first placing on the market of a product, whether this product is one of the definitions in accordance with § 2 (1) to (6) and, where appropriate, to decide on the classification and classification of the medical device. In doing so, the manufacturer or his authorised representative must have its registered office in Germany. Within the framework of this procedure, it may obtain an opinion from the classification and classification advisory board in accordance with § 5b.

(2) The Federal Office for Health and Safety in the Public Health Service may also make findings pursuant to paragraph 1 from its own account. It may also obtain an opinion from the classification and classification advisory board in accordance with § 5b.

(3) The costs of expert opinions shall be borne by the applicant.

Boundary and classification advisory board

§ 5b. (1) In order to advise the Federal Minister of Health and the Federal Office for Health and Safety in the field of health care in matters relating to the delimitation of medical devices to other products, as well as for the preparation of expert reports on whether a product is one of the definitions According to § 2 (1) to (6) and if necessary the classification of the medical device, the Federal Ministry of Health shall establish a Advisory Board (Advisory Board and Classification Advisory Board).

(2) In order to clarify issues of demarcation of medicinal products for medicinal products, the Advisory Board must meet in accordance with section 49a of the joint meeting with the Commission (demarcation advisory board) in accordance with Section 49a of the AMG.

(3) The Federal Minister of Health has to appoint qualified persons as permanent members for the duration of five years. The composition must be taken into consideration to ensure a balanced occupation with regard to the products or product groups eligible for the delimitation and classification of the products.

(4) Depending on the nature of the subject to be treated, the deliberations of the Advisory and Classification Advisory Board may be considered as non-permanent members on a case-by-case basis, as appropriate persons.

(5) For the period referred to in paragraph 3, the Federal Minister of Health shall entrust a staff member of his Ministry with the Presidency of the Advisory Council on the Boundary And Classification Advisory Board.

(6) For each member as well as for the chairman, a deputy shall be appointed.

(7) All members, as well as the Chairperson and their alternates, shall have a vote. Deputits shall have such a right to vote only in the event of the prevention of those persons representing them.

(8) The activities of the Advisory and Classification Advisory Board shall be carried out in accordance with a point of order to be adopted by the Federal Minister of Health.

(9) The activity in the classification and classification advisory board shall be without prejudice to paragraph 10. Any travel expenses shall be the members of the Abboundary and Classification Advisory Board, their deputiors and experts, after the highest level of travel fees in 1955, BGBl. 133, to replace it on request.

(10) The members of the Abboundary and Classification Advisory Board, which have been entrusted by the Federal Office for Safety in the Health Care with the preparation of relevant expert opinions, are due to receive one in relation to the Mühewaltung and the time spent adequate compensation to be paid by the applicant. "

(15) § 8 shall be added to the following paragraphs 4 and 5:

" (4) Medical devices in accordance with § 4a (1) must also comply with the relevant essential health and safety requirements of Directive 89 /686/EEC.

(5) Where there is a relevant risk in the case of medical devices within the meaning of Article 4a (2), they must also comply with the basic health and safety requirements set out in Annex I to Directive 2006 /42/EC, provided that such basic health and safety requirements are met Health and safety requirements are more specific than the essential requirements laid down in Annexes I to Directives 90 /385/EEC or 93 /42/EEC. "

16. In § 15 (2) the introduction words are:

"(2) Medical products may only be labelled with the CE marking if they are detectable"

17. § 22 (2) and (3) are:

" (2) If there are reasonable grounds for suspecting that a CE marking has been unlawfully affixed in breach of this federal law or is missing in violation of this federal law, the Federal Office for Safety in Health shall have appropriate measures to to initiate the monitoring in accordance with § 68, to carry out or to arrange for the necessary assessments and investigations, or to arrange for the person or entity producing or placing the medical device on the market to carry out the medical device of a Notified body, an otherwise suitably accredited body, or a notified body, to submit the reports and the results to the experts in order to clarify the legality of the affixing or the absence of the CE marking. The bodies or experts shall be selected in agreement with the Federal Office for Safety in Health.

The person or body producing or placing on the market the medical device shall bear the costs of the supervision, the examination or the other measures referred to in paragraph 2 if the CE marking has been wrongly affixed or is to be carried out under the conditions laid down in paragraph 2. Violation of this federal law is missing. "

18. § 23 reads:

" § 23. (1) If the Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) finds that the CE marking has been affixed unlawfully or in violation of this Federal Act, or if it does not provide evidence in accordance with § 15 para. 2 within a reasonable period of time , the manufacturer or his authorised representative shall be obliged, without prejudice to § 77, to prevent the further infringement under the conditions specified by the Federal Office for Safety in the Public Health Service in a modest manner.

(2) If the conditions laid down in paragraph 1 are not fulfilled, the Federal Office for Health Security shall take all appropriate measures in accordance with the procedure laid down in § 77 in order to restrict the placing on the market of the product in question or , or to ensure that it is withdrawn from the market. The manufacturer or his authorised representative shall immediately comply with those measures. "

19. In accordance with § 26, the following sections 26a and 26b and the heading are inserted:

" European method of demarcation, classification and the derogation clause

§ 26a. In accordance with § 5b, the Federal Minister of Health after referral to the Advisory Council, is of the opinion that, in accordance with technical progress and the information available on the basis of § 70, an adjustment of the classification rules in accordance with Annex IX of the Directive 93 /42/EEC, it may submit a duly substantiated request to the European Commission and call on it to adopt the measures necessary to adapt the classification rules.

§ 26b. The Federal Minister of Health has to submit a duly substantiated request to the European Commission and invite them to take the necessary measures if, after referral to the Advisory Council in accordance with Section 5b, it is of the opinion that:

1.		the application of the classification rules referred to in Annex IX to Directive 93 /42/EEC requires a decision on the classification of a specific medical device or type of medical device, or
2.		a specific medical device or series may be classified in another class by way of derogation from the provisions of Annex IX to Directive 93 /42/EEC; or
3.		the conformity of a medical device or a series of products, by way of derogation from Article 11 of Directive 93 /42/EEC, or by way of derogation from Article 9 of Directive 90 /385/EEC, shall be established in the exclusive application of a particular procedure which: be selected from the procedures provided for in Article 11 of Directive 93 /42/EEC or from the procedures laid down in Article 9 of Directive 90 /385/EEC; or
4.		a decision is required as to whether a given product or product group is subject to one of the definitions in Article 1 (2) (2). (a) to (e) of Directive 93 /42/EEC or one of the definitions referred to in Article 1 (2) (a), (c), (d) or (e) of Directive 90 /385/EEC, or
5.		the list of products listed in Annex II to Directive 98 /79/EC is to be amended or extended; or
6.		the conformity of a product or group of products, by way of derogation from the provisions of Article 9 of Directive 98 /79/EC, should be established in the application of one or more alternative methods which are derived from those referred to in Article 9 of the Directive 98 /79/EC. '

20. § 28 para. 2 Z 4 reads:

" 4.		those conformity assessment procedures, which may be initiated by the authorised representative, if necessary, "

21. In § 29 (1) the word sequences are deleted "established within the scope of the Agreement on the European Economic Area" and "established within the scope of the Agreement on the European Economic Area" .

22. § 34 reads:

" § 34. Any natural or legal person, the systems or treatment units referred to in § 33 or other medical devices of Directive 93 /42/EEC with CE marking, for which the manufacturer has provided for sterilisation prior to their use, for the for the first time shall be sterilized for the first time, one of the procedures referred to in Annexes II or V to Directive 93 /42/EEC shall apply. The application of these Annexes and the participation of the notified body shall be limited to the aspects of the sterilisation process in order to achieve the sterility of the medical device up to the opening or damage of the packaging. The person or company must make a declaration stating that sterilisation has been carried out in accordance with the manufacturer ' s instructions. "

23. In § 36 (2), the word "Monitoring Centre" by the word "Inspection Body" replaced.

24. § 37 (9) reads:

" (9) The notified body must:

1.		the Federal Ministry of Health on all certificates issued, amended, supplemented, suspended, revoked or refused, and
2.		the other bodies designated under Directives 90 /385/EEC, 93 /42/EEC and 98 /79/EC concerning all certificates issued, revoked or refused, and on request for certificates issued
to inform. The notified body must also make available on request all relevant additional information. "

Section 37 is added to the following paragraph 12:

"(12) The Federal Minister of Health may, by means of a Regulation, adopt uniform requirements for the designation, monitoring and activities of relevant designated bodies."

26. The title of the 1. Section of the III. The main item is:

"Clinical evaluation and performance assessment"

27. § 38 reads:

" § 38. (1) The proof that the sections 1 and 2 of Annex I to Directive 90 /385/EEC, or the characteristics and performance requirements referred to in Annex I (1) and (3) of Directive 93 /42/EEC are met by a medical device under normal conditions of use, and the assessment of undesirable side effects and of the Acceptability of the benefit/risk ratio, to which point 5 of Annex I to Directive 90 /385/EEC, or referred to in Annex I, Section 6 of Directive 93 /42/EEC, shall be based in principle on clinical data.

(2) The evaluation of these clinical data, hereinafter referred to as "clinical evaluation", where appropriate harmonised standards shall be taken into account, shall be carried out in accordance with a defined and methodically sound procedure. on the basis of a critical assessment

1.		the available relevant scientific literature on the safety, performance, design characteristics and purpose of the medical device, where:
a)			to demonstrate the similarity of the medical device with the medical device to which the data relate; and
b)			the data have to be duly substantiated in accordance with the relevant essential requirements; or
2.		the results of all clinical trials carried out, or
3.		of combined clinical data according to Z 1 and 2.

(3) Clinical trials shall be carried out in the case of active implantable medical devices and in the case of implantable medical devices and medical devices of class III of Directive 93 /42/EEC, unless the use of existing clinical data is shall be sufficiently substantiated.

(4) The clinical evaluation and its outcome shall be documented. This documentation or a detailed reference to it shall be included in the technical documentation relating to the medical device.

(5) The clinical evaluation and its documentation must be kept up-to-date on the basis of the data obtained from post-marketing surveillance. Where a post-marketing clinical monitoring is not considered necessary after placing on the market, this must be justified and documented.

(6) It is considered that the manufacturer or his authorised representative is not required to demonstrate compliance with the essential requirements on the basis of clinical data within the meaning of paragraph 1 of this Article, such an exception shall be consistent with the following: for the reasons. This justification shall be based on the outcome of risk management and shall take into account the specificities of the interaction between the body and the medical device, the intended clinical performance and the information provided by the manufacturer. The suitability of the proof of conformity with the essential requirements solely by means of performance evaluation, product testing and preclinical evaluation shall be justified separately.

(7) The evidence that the performance requirements referred to in Annex I, Chapter A, Section 3 of Directive 98 /79/EC are met by an in vitro diagnostic agent under normal conditions of use, as well as the assessment of risks and of the risks associated with the Acceptability of the benefit/risk ratio referred to in Annex I, Chapter A, Section 1 of Directive 98 /79/EC shall, in principle, be carried out on the basis of performance data.

(8) The evaluation of the performance data referred to in paragraph 7, hereinafter referred to as "performance assessment", where appropriate the common technical specifications and relevant harmonized standards shall be taken into account, shall be assessed in accordance with a -defined and methodically sound procedures based on a critical assessment

1.		the available relevant scientific literature on safety, performance, design characteristics and purpose of the in vitro diagnostic test, where:
a)			to demonstrate the similarity of the in vitro diagnostic test with the in vitro diagnostic agent to which the performance data relate; and
b)			the performance data have to be adequately substantiated in accordance with the relevant essential requirements; or
2.		the results of all the performance assessment tests carried out, or
3.		from published or unpublished reports on other clinical experience with the in vitro diagnostic agent or similar in vitro diagnostic agent, its similarity to the in vitro diagnostic agent in question can be detected, or
4.		of combined performance data according to Z 1 to 3.

(9) The performance assessment and its result should be documented. This documentation or a detailed reference to it shall be included in the technical documentation relating to the in vitro diagnostic agent. The performance assessment and its documentation shall be kept up-to-date on the basis of the performance data obtained from the post-market surveillance. "

§ 40 reads:

" § 40. (1) In the case of clinical testing of medical devices, the sponsor shall have the following in Annex 6 to Directive 90 /385/EEC, in Annex VIII to Directive 93 /42/EEC, in the performance assessment test of in vitro diagnostic medical devices, as set out in Annex VIII to Directive 98 /79/EC to apply procedures.

(2) The clinical examination of active implantable medical devices in accordance with Directive 90 /385/EEC and of class III medical devices or implantable or long-term invasive medical devices of classes IIa or IIb in accordance with Directive 93 /42/EEC may be commenced by the relevant Ethics Committee and reimbursement of a proper notification to the Federal Office for Health and Safety in accordance with Directive 93 /42/EEC, provided that the Federal Office of Security in the health sector not within 60 days of the date of proper notification of the clinical trial the clinical trial for the protection of the participants in the examination, public health or other non-compliance with the requirements of section 41 (4) prohibits or before the expiry of this period the Implementation of the clinical trial approved.

(3) The clinical examination of medical devices referred to in Directive 93 /42/EEC, not mentioned in paragraphs 2 and 5, and the performance assessment tests of in vitro diagnostic medical devices referred to in Directive 98 /79/EC, which are not mentioned in paragraph 5, may, in accordance with the provisions of Directive 93 /79/EC, be: A favourable opinion by the relevant Ethics Committee and a refund of a proper notification to the Federal Office for Safety in the Health Care Centre will be started.

(4) The notification to the Federal Office for Health Security shall be made, including the declaration referred to in the annexes to the Annexes referred to in paragraph 1. The documentation provided there is to be made available immediately upon request.

(5) The clinical examination of medical devices in accordance with Directive 93 /42/EEC, which shall bear the CE marking in accordance with Article 15, may-unless the clinical trial is otherwise intended to determine the intended purpose of the medical device as the one in the conformity assessment procedure. , and the clinical trial does not require any additional diagnostic or therapeutic measures, which shall be initiated by the relevant Ethics Committee, in accordance with a favourable opinion. In the performance assessment test of in vitro diagnostic medical devices in accordance with Directive 98 /79/EC, which bear the CE marking in accordance with § 15, the performance assessment test may not be a different purpose of the in vitro diagnostic test than the one in the After a favourable opinion has been received by the relevant Ethics Committee, the subject-matter of conformity assessment shall be commenced. § 47 shall not apply.

(6) The sponsor shall conclude the clinical trial of the Federal Office for Health and Safety and the competent authorities of other interested parties to the EEA, in the event of an early termination, on the basis of such a justification, to report. This notification shall also be made to the competent authorities of all other Contracting Parties to the EEA and to the European Commission, if the premature termination is made for safety reasons. The final report referred to in Annex 7, Section 2.3.7 of Directive 90 /385/EEC, or Annex X, Section 2.3.7 of Directive 93 /42/EEC shall be available to the Federal Office for Health and Safety and the competent authorities of the other Contracting Parties to the EEA.

(7) Notifications pursuant to paragraphs 1, 2, 3 and 6, § 40b and § 42 (8) must be made in accordance with a regulation in accordance with § 67 by means of the European database for medical devices. "

29. In accordance with § 40, the following § § 40a and 40b shall be inserted together with the headings:

" Change of the audit plan

§ 40a. (1) After the start of the clinical trial, the sponsor may change the test plan. If the change is significant and in particular can affect the safety of the test participants or may influence the scientific validity of the clinical trial, the sponsor shall have clinical trials in accordance with § 40 (2) and (3). To report the contents of the amendment and all the reasons for it to the Federal Office for Health and Safety in the Health Care and the Ethics Committee responsible. In the case of clinical trials in accordance with § 40 (5), the sponsor of the relevant Ethics Committee shall report the content of the amendment and all reasons for it.

(2) In the case of a clinical trial in accordance with § 40 (2), the amendment may be made in accordance with the favourable opinion of the relevant Ethics Committee for a notification in accordance with paragraph 1, unless the Federal Office for Security in the Health Sector does not within a period of 35 days after due notification of the amendment the clinical trial for the protection of the participants in the examination, the public health or because of other non-compliance with the requirements of § 41 (4) prohibits or before the end of the period the time limit for the implementation of the amendment has been approved.

(3) In the case of a clinical trial in accordance with § 40 (3), the amendment may, in accordance with the favourable opinion of the relevant Ethics Committee, be entitled to a notification in accordance with paragraph 1 and reimbursement of the notification pursuant to paragraph 1 to the Federal Office for Safety in the Health Care shall be made.

(4) In the case of a clinical trial in accordance with § 40 (5), the amendment may be made in accordance with the favourable opinion of the relevant Ethics Committee for a notification in accordance with paragraph 1.

(5) Without prejudice to the provisions of paragraphs 1 to 4, the sponsor and the clinical examiner shall, in the case of any new circumstance relating to the conduct of the examination or the development of the medical device in clinical trials, shall have the safety of the participants in the examination or the development of the medical device. Users may be able to take the necessary security measures to protect the participants or users from imminent danger. In the case of clinical trials in accordance with § 40 (2) and (3), they shall immediately inform the Federal Office for Safety in Health Care and the relevant Ethics Committee about these new circumstances and the measures taken. In the case of clinical trials in accordance with § 40 (5), they shall immediately inform the relevant Ethics Committee about these new circumstances and the measures taken. The reporting obligations pursuant to § 70 shall remain unaffected.

Suspension or undersawing of clinical trial

§ 40b. (1) Insofar as the Federal Office for Health Security has objective reasons to believe that the conditions of the notification are no longer met in accordance with § 40 (2) and (3), or that it has information concerning the safety of the health of the health care system. or the scientific basis of a clinical trial, the clinical trial shall be subject to the clinical trial or to be subject to a lower clinical trial. Prior to the decision, the sponsor shall be heard and informed by the clinical examiner, except in the case of danger in default (§ 57 of the AVG). The sponsor has to deliver its opinion within a week.

(2) The Federal Office for Health Security shall, if it suspends or prohibits the conduct of a clinical trial, shall have the other Contracting Parties to the EEA, the relevant Ethics Committee, and the European Commission, specifying the Reasons for his decision to suspend or prohibit the clinical trial. If the Federal Office for Health Security has ordered a substantial change to a clinical trial, it has the other Contracting Parties to the EEA where the clinical trial is carried out and the competent authorities of the competent authorities responsible for the safety of the health and safety of the patient. to inform the Ethics Committee of its actions and their justification.

(3) If the Federal Office for Health Security has reasons for the assumption that the sponsor or the clinical examiner or any other person involved in the clinical trial no longer fulfils his obligations, it shall have the right to to give him the opportunity to comment immediately and then to inform him of an action plan which he must carry out in order to remedy the situation. This is true even if the clinical trial has already been completed. Reporting obligations as referred to in paragraph 2 shall remain unaffected. "

The following paragraph 6 shall be added to section 41:

" (6) In the planning, installation, implementation and evaluation of clinical trials of medical devices and performance assessment tests of in vitro diagnostic medical devices, the ethical principles for medical research at the person of the declaration are from Helsinki of the World Medical Association, in the version of the 59. General Assembly of the World Medical Association, Seoul, October 2008, to be observed. "

31. § 42 (8) reads:

" (8) All serious adverse events shall be fully registered by the sponsor and shall immediately be registered by the Federal Office for Health and Safety and the competent authorities of the other Contracting Parties to the EEA in which the clinical trial, to be reported. "

32. § 44 reads:

" § 44. In particular, the following documentation and documents must be drawn up for each clinical trial and must be submitted to the Federal Office for Safety in Health Care:

1.		the audit plan;
2.		the manual of the clinical examiner,
3.		the information to be used for the reconnaissance of the participants in the examination and, where applicable, their legal representatives pursuant to § 51, and the declaration of consent,
4.		the provisions relating to insurance cover within the meaning of sections 47 and 48 thereof;
5.		the agreements between the sponsor, monitor and clinical auditor, who determine their responsibilities,
6.		the opinions of all the ethics committees to be considered and the views which have been the subject of these Opinions, and
7.		the final report. "

33. § 49 reads:

" § 49. (1) The clinical examination of a medical product may only be performed if the examination participant has been informed by a doctor or dentist of the purpose, significance, scope, benefits, risks and strains of the clinical trial and has given his consent to participate in the clinical trial.

(2) The Enlightenment must be sufficiently clear and easily comprehensible to the participants in the examination, so that it can make the decision on the consent to participate in the clinical trial in full knowledge of the relevant facts.

(3) The Enlightenment must be given both verbally and in writing. It must make it clear that a refusal to participate in the clinical trial or the withdrawal from the clinical trial at any time without adverse consequences, in particular for the further medical care of the Test participant, remains. If necessary, the Enlightenment must also include the medical consequences of leaving the clinical trial at certain points in time.

(4) The examiners shall be informed of the purpose and extent of the collection and use of personal data. In this context, the participants in the examination shall in particular be informed that data

1.		can be checked by the monitor, during an audit, and during an inspection by the authority; and
2.		encrypted to the sponsor. "

34. § 50 (1) and (2) reads:

" (1) If a participant agrees to participate in the participation after extensive information, his consent must be recorded in written form. The consent must be dated and given with the signature of the examination participant. If the participant is not in a position to do so, the consent must be given before a witness who has to confirm his/her consent by signing his/her signature. With the consent, explicit data protection consent is also to be obtained.

(2) The consent is only legally effective, unless § 51 is determined otherwise, if the test participant is able and capable of seeing the nature, meaning, scope, benefits, risks and burdens of the clinical trial and his/her Will then determine the will. "

35. § 50 (4) reads:

" (4) The examiners, if necessary the guardians or guardians. of the Sachwalter, must be informed in writing of the insurance cover in accordance with § 47. "

36. § 51 reads:

" § 51. (1) The clinical examination of a medical product may only be carried out on minors if:

1.		the medical device being tested for the achievement of an intended purpose in accordance with Article 2 (1) for minors, and the clinical trial for the validation of data obtained in clinical trials in adults or by means of other research methods, it is absolutely necessary to
2.		the application of the medical device, which is considered, is indicated by the findings of medical science, in order to achieve a specific purpose in the case of the minor in which the clinical trial is carried out, in accordance with Article 2 (1); and the benefit of inclusion in the clinical trial outweighs the risk for the test participant,
3.		the consent of the legal guardian has been shown to be verifiably and in writing after appropriate clarification,
4.		the minor, prior to the commencement of the clinical trial, has received, by means of a clinical examiner, experienced in dealing with minors, one of his ability to understand the relevant information;
5.		the consent of the minor, who is able to see the nature, the importance, the scope and risks of the clinical trial and its determination to be identified, and to ensure that the person who is a minor expressed desire not to participate in the clinical trial or to terminate it at any time shall be taken into account by the clinical examiner,
6.		the consent can be revoked at any time without any disadvantage to the minor,
7.		no incentives or financial benefits, with the exception of compensation for costs, are linked to the participation in the clinical trial,
8.		the clinical trial is planned to be associated with the least possible pain, discomfort, anxiety and other foreseeable risks, taking into account the disease and the development stage of the minor, with the following: the risk threshold as well as the degree of stress must be specifically defined and constantly reviewed,
9.		the audit plan is supported by an Ethics Committee, which has knowledge of the field of children's and adolescents ' medicine or who has been advised in clinical, ethical and psychosocial questions in the field of child and youth medicine. , and
10.		In doubt, the interests of the patient are always above the public interests and the interests of the scientific community.

(2) By way of derogation from paragraph 1 (2), a clinical trial on minors shall be permitted even if:

1.		the clinical trial is an essential extension of the scientific understanding of the condition, disease or malfunction of the minor, and thereby either the patient or the group of patients who are the minor is a member of the European Parliament, and
2.		the clinical trial for the minor entails minimal risk and minimal exposure; a clinical trial has a minimal risk and a minimal burden, if it is expected that it will not exceed a minimum risk of exposure to the risk of the child. minor and merely temporary impairment, and any symptoms or inconvenience may be very slight and will only occur temporarily. "

37. § 52a (3) reads:

" (3) The patient acquires the ability to consent, so he is immediately informed that a clinical trial in an emergency situation has been or will be carried out on him. It is to be clarified in the sense of § § 49 and 50. A continuation of the clinical trial is only permissible if consent is given to the Enlightenment, including the explicit consent for data protection. The use of the data determined up to that point requires the explicit consent of the data protection. "

38. § 56 (3) reads:

" (3) Test bodies, facilities, including laboratories, as well as any type of data shall be for a review by the relevant Ethics Committee and for an inspection by the Federal Office for Safety in the Health Care or by a Foreign "To make public health authority accessible after advance notice."

39. In accordance with Article 56 (3), the following paragraphs 4 to 7 are added:

" (4) The objective of an inspection is to determine, by means of objective, independent verification, whether the standard prescribed in this Federal Act is complied with with regard to the planning, implementation and evaluation of clinical trials. The aim of an inspection of an Ethics Committee may also be to determine, by means of objective, independent verification, whether the Ethics Committee fulfils its tasks in accordance with the state of the art in accordance with this federal law.

(5) Ethics commissions shall be obliged to provide the Federal Office for Health Security with all information and documents necessary for the fulfilment of its tasks in accordance with this section.

(6) If an inspection finds that a clinical trial is conducted contrary to the provisions of this Federal Act, or concerns arise regarding the safety or the scientific basis of the clinical trial, the clinical trial shall be subject to a clinical trial. The Federal Office for Health and Safety (Bundesamt für Sicherheit im Sicherheit im Health) may also take measures within the meaning of § 40b (1) without prior procedure or before leaving examination and will thereby endanger the life or health of test participants or users. of a seizage, but shall be subject to this within two weeks in writing, the measure shall be deemed to have been repealed.

(7) In the course of the inspection of a clinical trial, the Federal Office for Health and Safety in the Health Care Health Service shall be required to charge the sponsor unless the clinical examiner takes the tasks within the meaning of Section 3 (5). of the sponsor. "

40. § 59 (1) reads as follows:

" (1) The members of the Ethics Committee and their alternates shall be free of instruction in this function. You have to disclose all possible relationships with manufacturers or distributors of medical devices with regard to the Governor of the State. They have to abstain from their activities in the Ethics Committee-without prejudice to any further grounds of concern-in all matters in which such a relationship is appropriate, to cast doubt on their full unpartiality. "

41. According to Article 59 (1), the following paragraph 1a is inserted:

"(1a) Within the framework of the organisation, internal quality assurance measures shall be provided, which shall in particular ensure the regularity of the procedures and procedures."

Section 60 (2) reads as follows:

" (2) The Ethics Committee shall record its opinions in written form with reference to the documents submitted. The opinion on a clinical trial is within 60 days to deliver the opinion on an amendment to the examination plan within 35 days and at the same time to submit the opinion to the Federal Office for Health Security. "

43. § 61 reads:

" § 61. The clinical examiner shall immediately inform the Ethics Committee about all serious adverse reactions in the context of the clinical trial. The reporting obligations of § 70 shall remain unaffected. "

44. In accordance with Section 63 (4), the following paragraphs 5 and 6 are added:

" (5) The sponsor has to assess the audit plan and confirm by signing it.

(6) The sponsor may delegate the performance of his duties or obligations in full or in part to external scientific institutions. "

45. § 64 (1) reads:

" (1) Clinical examiner may only be a suitably qualified person, who is responsible for the self-employed exercise of the medical and/or medical dental profession in Austria authorized physician or be a dentist who

1.		is designed and experienced in the field of application of the medical device to be tested, and
2.		is familiar with the background and requirements of the clinical trial and can demonstrate at least two years of experience in clinical trials. "

46. In accordance with Article 64 (6), the following paragraph 7 is added:

"(7) The clinical examiner shall make available to all staff members who are involved in the conduct of the clinical trial or in the supervision of the test participants all the information relevant to them."

47. § 65 reads:

" § 65. (1) The monitor has

1.		to establish the communication between the sponsor and the clinical auditor and to ensure, on behalf of the sponsor, the appropriate monitoring of the clinical trial,
2.		to work according to the standard work instruction (SOP), to review the clinical auditor before, during and after the completion of the clinical trial, in order to check compliance with the test plan and to ensure that all data are correct and shall be fully recorded and recorded, and
3.		to compare the entries in the test sheets with the original findings and to inform the clinical examiner of errors and omissions.

(2) The monitor must have those qualifications that enable him to provide expert supervision of the clinical trial. "

48. § 65a (1) reads:

"(1) The provisions of Sections 39, 40 (1), 3, 4, 5 and 7, 40a and 40b, 41 to 44, 45 (2), 46 to 64 shall also apply to performance assessment exams, unless otherwise determined by paragraph 2."

Section 65a (2) reads as follows:

" (2) Insofar as a performance assessment test of an in vitro diagnostic agent does not provide for a specific sampling of test participants or additional medical examinations or treatments in accordance with the type or quantity of the in vitro diagnostic test, or in the case of a § § § 47 to 54 do not apply to the performance assessment test of in vitro diagnostic medical devices. "

Section 67 (7) reads as follows:

" (7) The Federal Minister of Health may, in the light of the uniformity of the notifications and the information required for the monitoring of medical devices, by means of a regulation of the type, content, form and procedure of the notifications in accordance with the para. 1 to 5. In the case of active implantable medical devices, in the case of medical devices of classes IIa, IIb and III of Directive 93 /42/EEC and in the case of in vitro diagnostics of Anhange II and in vitro diagnostic medical devices for the self-application of Directive 98 /79/EC, the Federal Minister of Health, the communication of all information enabling the identification of the medical device and the identification and instructions for use, if these medical devices are in the scope of this Federal Law in Operation is taken. In this Regulation, the Federal Minister for Health may also determine the reporting requirements, modalities and access rights with regard to the European database within the meaning of Directives 90 /385/EEC, 93 /42/EEC and 98 /79/EC. "

The following paragraphs 11 to 13 are added to § 68:

" (11) Market Surveillance Authority within the meaning of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down rules for accreditation and market surveillance relating to the marketing of products and to the market surveillance authority Repeal of Regulation (EEC) No 339/93 for products within the meaning of this Federal Act is the Federal Office for Security in the Health Care.

(12) The Federal Office for Health Security has to draw up and regularly update and implement market surveillance programmes for medical devices in accordance with the requirements of the Federal Ministry of Health. These are to be submitted to the Federal Minister of Health for approval. The Federal Office for Health and Safety (Bundesamt für Sicherheit in Healthcare) has to inform the other Member States and the European Commission and to inform the public by means of electronic means of communication and, where appropriate, by other means. To be made available.

(13) The Federal Ministry of Health shall regularly, at least every four years, review and evaluate the functioning of the market surveillance activities of the Federal Office for Safety in Health Care. The results of these verifications shall be communicated to the other Member States and to the European Commission and shall be made available to the public by means of electronic means of communication and, where appropriate, other means. "

Section 70 (1) reads as follows:

(1) members of a statutory health professional, a professional who is authorised to operate or to use a medical device, head of relevant testing, inspection and certification bodies and technical Security officers of hospitals shall have information on medical devices with regard to incidents, in particular:

1.		any malfunction or change in the characteristics or performance of a medical device, or any defect in relation to the marking or instructions for use which are likely to cause death or serious deterioration of the the health status of a patient, of a user or of a third party, or who has led to it, or
2.		Previously unknown serious side effects or the increased occurrence of known serious side effects, or
3.		previously unknown mutual influences, or
4.		serious quality defects,
which have become known to them as a result of their professional activity, to report immediately to the Federal Office for Health Security and to communicate all observations and data that may be of importance for medical device safety. "

53. § 70 (3) and (4) are:

" (3) All natural or legal persons who place medical devices on the market for the first time in the EEA and those establishments, facilities or persons who place medical devices on the market have the Federal Office for Safety in Health immediately incidents referred to in paragraph 1 and, in addition, corrective measures, such as:

1.		any technical or medical reason associated with a medical product which has resulted in the systematic recall of medical devices of the same type from the market by the manufacturer,
2.		the issuing of a policy recommendation,
3.		the additional monitoring or modification of products,
4.		modifications of the product design of components or of the manufacturing process; and
5.		Modifications of the marking or the instructions for use
.

(4) The Federal Office for Health Security shall take the necessary measures to ensure that the person responsible for the first placing on the market in the EEA is also informed of an incident referred to in paragraph 1. "

Section 70 shall be added to the following para. 6 and 7:

" (6) All natural or legal persons who place medical devices on the market for the first time in the EEA and those establishments, facilities or persons who place medical devices on the market are obliged to use their reporting and reporting requirements. to comply immediately and verifiably with information obligations relating to the incidents referred to in paragraph 1 and the measures referred to in paragraph 3 in relation to the Contracting Parties to the EEA, in accordance with Directives 90 /385/EEC, 93 /42/EEC and 98 /79/EC.

(7) After the Federal Office for Health and Safety has assessed an incident in accordance with paragraph 1 and measures in accordance with paragraph 3, if possible jointly with the manufacturer or his authorised representative, it has the European Commission and the following: to inform the other Member States without delay of the measures taken. This shall include information on the underlying incidents. "

55. In accordance with § 77 (1) Z 2 the following Z 2a is inserted:

" 2a.		the fulfilment of the requirements of Z 2 is insufficiently substantiated, or "

56. In § 77 para. 1 Z 3 the word "he" by the word "it" replaced.

57. According to Article 77 (2), the following paragraph 2a is inserted:

" (2a) The measures referred to in paragraph 1 may also cover medical devices whose release has been suspended by the customs authorities in accordance with Article 27 (3) of Regulation (EC) No 765/2008. The products concerned are, in this case, in temporary custody pursuant to Article 50 of Council Regulation (EEC) No 2913/92 of 12 June 1992. October 1992 establishing the Community Customs Code, OJ L 327, 31.12.1992, p. No. OJ L 302, 19.10.1992 (Customs Code). '

58. § 111 Z 5 reads:

" 5.		does not fulfil the conditions set out in § 23 (1) or does not comply with the measures provided for in Article 23 (2), "

59. § 111 Z 13 reads:

" 13.		in the case of clinical evaluation or performance assessment or in the clinical examination of a medical product, § § 38 to 65 or a regulation in accordance with § 66 is contrary, "

60. § 111 Z 15 reads:

" 15.		in the case of measures relating to the monitoring of its obligation to carry out or support these measures in accordance with § 22 para. 2 or § 68 (8) or § 69 (3), "

61. In § 113 the second sentence is deleted.

(62) § 114 is added to the following paragraph 9:

§ 2 para. 5c, § 2 para. 7, 8 and 8a, § 3 para. 2, 2a, 2b, 4, 5, 8, 9 and 15, § 4 para. 1 Z 1, 4 and 6, § 4a, § 5a and 5b including the headings, § 8 para. 4 and 5, the leading words of section 15 (2), § 22 para. 2 and 3, § 23, § § 26a and 26b, including the title, § 28 para. 2 Z 4, § 29 para. 1, the introduction words of § 33 para. 1, § 34, § 36 para. 2, § 37 para. 9 and 12, the title of the 1. Section of the III. Main piece, § 38, § 40, § § 40a and 40b with headlines, § 41 para. 1, 2, 4 and 6, § 42 para. 8, § 43, § 44, § 47 para. 1, 2 and 3, § 49, § 50 para. 1, 2 and 4, § 51, § 52a para. 3, § 56 para. 3 to 7, § 59 para. 1, 1a and 3, § 60 para. 1 to 3, § 61, § 63 4 to 6, § 64 (1), (4) and (7), § 65, § 65a (1) and (2), § 66, § 67 (7), § 70 (1), 3, 4, 6 and 7, § 77 (1) (2a) and (3), § 77 (2a), § 111 Z 5, 13 and 15, § 113, § 116 (2) and (3), § 116a (Z) 7, as amended by the Federal Law BGBl. I n ° 143/2009 will enter into force on 21 March 2010. Section 68 (11) to (13) in the version of the Federal Law BGBl. I n ° 143/2009 shall enter into force 1. Jänner 2010 in force. "

63. § 116 (2) and (3) are:

" (2) The Regulation on dental amalgam, BGBl. No. 575/1990, occurs at the end of the day of the proclamation of this Federal Law in the version of the Federal Law BGBl. I No 143/2009.

(3) The Regulation of the Convention of Condoms, BGBl. No. 630/1990, occurs at the end of the day of the presentation of this Federal Act in the version of the Federal Law BGBl. I n ° 143/2009. '

64. The point after Z 6 in § 116a is replaced by a stroke point, the following Z 7 is added:

" 7.		Directive 2007 /47/EC No. OJ L 247 of 5 September 2007).

Article 2

Amendment of the Medicines Act

The Federal Act of 2 March 1983 on the production and the placing on the market of medicinal products (pharmaceutical law), BGBl. No. 185, as last amended by the Federal Law BGBl. I n ° 63/2009, shall be amended as follows:

1. In Section 1 (6a), the phrase shall be: "as last amended by Directive 2004 /27/EC" through the phrase "as last amended by Directive 2009 /120/EC" replaced.

2. In § 20 (1) and § 20 (2), first sentence shall be followed in each case after the word order "a traditional herbal" a dash and the word "homeopathic" inserted.

(3) In § 20 (3), first sentence, after the word "Veterinary speciality" the phrase " or the registrant of a homeopathic drug speciality " inserted.

4. In § 94c (8), the last sentence is deleted.

Article 94c (10) reads as follows:

" (10) Also proprietary medicinal products which prior to the entry into force of this Federal Law in the version of the Federal Law BGBl. In accordance with § 19a of this Federal Act, the existence of the conditions for admission has already been approved in the version prior to the entry into force of the Federal Law BGBl (Federal Law Gazette). I n ° 153/2005, are subject to the provisions of § 20. The submission of the documents in accordance with § 20 (2) and 3 required documents shall be made by 30 June 2012 at the latest in the event of any other extinguisher of the authorisation. The Federal Office for Safety in the Health Care Office has issued a notice of the extinguisher. If a timely submission does not take place, the products may still be placed on the market until 31 December 2012. "

6. § 94c (12) reads:

" (12) For registered homeopathic proprietary medicinal products, the date of submission in accordance with § 20 (2) and (3) shall be calculated from a multiple of five years from the date of registration. The submission shall be made at the earliest on 30 June 2012. "

7. The headline before § 94d reads:

"Special provisions relating to crisis situations"

8. § 94e shall be named "§ 94f" , the following § 94e is inserted:

" § 94e. (1) As long as the World Health Organisation (WHO) has declared an influenza pandemic,

1.		a vaccine for vaccination against New Influenza A (H1N1) approved by the manufacturer or the marketing authorisation holder in accordance with the provisions of this Federal Act and approved for Austria directly by the manufacturer or the marketing authorisation holder
a)			Local authorities, and
b)			Distribution centres designated by the public authorities (local authorities, health insurance institutions and health care institutions)
		shall be delivered and
2.		the vaccine is used by local authorities, or Distribution centres to be given by the public authorities (local authorities, health insurance institutions and health care institutions) to specific vaccination centres. For the distribution of the vaccine, the manufacturer, the marketing authorisation holder, the local authorities and the distribution centres of third parties are able to use the vaccine.

(2) Medicinal products which, in the event of a catastrophe, terrorist threat, war, epidemic, pandemic or any other crisis situation, shall be subject to the bodies referred to in Article 57 (1) (5) and (5a) for the purpose of maintaining the the supply of medicinal products and kept in stock by them for the purpose of averting the risk posed by such a crisis situation may be carried out in their intended commercial packaging or in the form of a product or Original packaging to be delivered to manufacturers, depositors, pharmaceutical wholesalers, public pharmacies and Anstaltsapotheken.

(3) proprietary medicinal products, whether by a local authority or by a local authority, for the purposes of wasting one of a disaster, terrorist threat, war, epidemic, pandemic or other crisis situation; shall be kept in stock, may continue to be kept in stock even after the date of failure has been exceeded, and may be delivered for storage and, if there is a specific risk, provided on the basis of a professional Investigations by the Federal Office for Health Security noted that their quality and impact continue to be guaranteed. "

Fischer

Faymann