261. Regulation of the Federal Minister of health messages from manufacturers of medical devices or their agent, messages from inspection, monitoring, and certification authorities and notified bodies, reports of incidents and clinical trials, as well as messages to the European database for medical devices (medical product reporting regulation)
On the basis of § § 66, 67 paragraph 7 and 70 para 5 of the medical devices act - MPG, BGBl. No. 657/1996, as last amended by Federal Law Gazette I no. 143/2009, is prescribed:
§ 1 (1) shall apply to this regulation
1. releases from manufacturers or their agent, who bring a medical device for the first time within the scope of the European economic area (EEA) in traffic and are resident in the national territory, 2. are resident messages from manufacturers of custom-made products that bring a medical device for the first time within the scope of the EEA market and domestic, put together 3 messages by natural or legal persons, the medical devices referred to in article 33, paragraph 1 MPG or pursuant to § 34 sterilize MPG , and have their seat in Germany, 4. messages from points, institutions or persons, testing, monitoring or certification activities according to the medical product law berufs - or professional conduct, 5 messages from notified bodies, 6 reports of clinical tests and performance evaluation studies, 7 reports of incidents and 8 the process of exchanging data with Eudamed.
(2) the Gesundheit Österreich GmbH shall keep a register Z 1 to 5 used the collection of notifications referred to in paragraph 1.
§ 2. Within the meaning of this regulation means:
1. "Eudamed": the European database for medical devices in accordance with the decision of the Commission (2010/227/EEC) (OJ, 19 04 2010 L No. 102 23rd 04th 2010, S 45);
2. "Register": the register of the Gesundheit Österreich GmbH for medical devices;
3. "notified body": a body in accordance with § 2 para 16 MPG.
Messages on the Gesundheit Österreich GmbH
§ 3 (1) manufacturers or their representatives in accordance with § 1 para 1 Z 1, manufacturer of custom made pursuant to section 1 para 1 No. 2 as well as natural or legal persons pursuant to section 1 para 1 No. 3 products which fall under directives 93/42/EEC and 90/385/EEC before entering upon their duties on the Gesundheit Österreich GmbH in particular to report:
1. business name or name, address and information about the contact person of the manufacturer or of the agent, 2. when authorised representative of the manufacturer: Company name or name, address and information about the contact person of the foreign manufacturer, 3. type of activity (message type), 4. name, telephone number and email of the safety officer, 5. product name or-fabrikat or, if not available, generic name (generic name), 6 code of an internationally recognized nomenclature for medical devices , 7 type, 8 category of the medical device, 9 species of the medical device and 10 information on the professional or business license.
(2) manufacturers or their representatives in accordance with § 1 para 1 subpara 1 have for products that fall, before entering upon their duties on the Gesundheit Österreich GmbH in addition to the already under paragraph 1 in particular to log Z 1 to 7 and 10 listed claims under the Directive 98/79/EC:
1 IVD Classification, 2. indicate whether it is a new product in accordance with the Directive 98/79/EC, 3. conformity assessment by notified body for IVD in accordance with annex II of to Directive 98/79/EC or IVD for self-testing, 4. conformity with common technical specifications for IVD in accordance with annex II, list A of Directive 98/79/EC-5, where appropriate, results of performance evaluation.
(3) categories, institutions or persons referred to in article 1, paragraph 1 Z 4 to sign before taking up their duties on the Gesundheit Österreich GmbH in particular:
1 company name or name, address and details of the contact person, 2. type of activity, 3. information to professional or business license, 4 medical product categories and 5. where appropriate, indicate whether it is an accredited body in accordance with article 90, par. 2 MPG.
(4) the notified bodies have information relating to certificates, which in accordance with the procedures of in annexes 2 to 5 of Directive 90/385/EEC, annexes were II to VII of the Directive 93/42/EEC and annexes III to VII of Directive 98/79/EC issued, modified, supplemented, suspended, withdrawn or denied, notify the Gesundheit Österreich GmbH. This message has to be done once per month, and in particular to contain:
1. number and type of certificate, 2. date of issue, 3.
End of validity, 4 number of the notified body, 5. company name or name, address and information about the contact person of the manufacturer or the authorised representative, 6 names: General description the validity, 7 details concerning the product (such as product name or-fabrikat or, if not available, common name, generic name) and 8 State and, where appropriate, the reasons for the decision.
Form of the messages on the Gesundheit Österreich GmbH
4. (1) messages according to § 3 para 1 to 3 have to be done online via a Web-based form to the register. Notifications pursuant to § 3 para 4 have to be done, which is to publish on the website of Gesundheit Österreich GmbH from this electronically via a form. The Gesundheit Österreich GmbH has to enter data according to § 3 para 4 in the register.
(2) the notifying parties pursuant to § 3 para 1 to 3 are responsible for the accuracy and completeness of their messages.
(3) the notifying parties pursuant to article 3 have subsequent changes, corrections or additions of data transmitted forthwith.
(4) the Gesundheit Österreich GmbH has data security measures in accordance with §§ 14 ff Data Protection Act 2000, Federal Law Gazette I no. 165/1999, as last amended by Federal Law Gazette I no. 135/2009, to take.
Messages to the Federal Office for security in healthcare
Members of a regulated health profession, business legitimate, that are entitled to the use of a medical product or professional to operate, head of relevant testing, monitoring, and certification authorities and technical security officers of hospitals have § 5 (1) medical devices directives 90/385/EEC, 93/42/EEC and 98/79/EC incidents, in particular
1. any malfunction or deterioration in the characteristics or performance of a medical device as well as any defect in relation to the labelling or the instructions are suitable, to the death or a serious deterioration in the State of health of a patient, of a conducted user/user or of a third party to conduct or intended, or so far unknown serious side effects or the occurrence of known adverse reactions increased 2. , or previously unknown reciprocal influences, or 4. immediately to report serious quality deficiencies, which are known to them on the basis of their professional activity, the Federal Office for security in the health care sector, as well as all observations and data to be communicated, for the medical product safety can be 3.
(2) any natural or legal persons who bring medical products in the EEA for the first time in traffic and bring those companies or persons, the medical devices on the market, have incidents referred to in paragraph 1 and Moreover, corrective measures, how about
1 any technical or medical reason associated with a medical device, which has led to the systematic recall of devices of the same type from the market by the manufacturer, 2. the exhibition of measure recommendation, 3. the additional monitoring or modification of products, 4. modifications of the product design of components or of the production process and 5. modifications of the labelling or instructions the Federal Office for security in the health service immediately to report.
Clinical testing and performance evaluation studies
Section 6 reports of clinical trials or by performance evaluation studies and reports of their accounts according to § 40 MPG, notifications of changes to the inspection plan in accordance with § 40a MPG, as well as reports of serious adverse events according to § 42 para 8 MPG have products of the directives 90/385/EEC to 93/42/EEC and 98/79/EC to the Federal Office for security in healthcare.
Form of messages to the Federal Office for security in healthcare
§ 7 (1) the reports pursuant to paragraphs 5 and 6 must be done which are to publish on the website of the Federal Office for security in the health care sector of this electronically by means of login forms.
(2) on the registration forms referred to in paragraph 1 any personally identifiable information may be included with the exception of information relating to registered persons or institutions.
Messages on Eudamed
8. (1) the data pursuant to § 3 paragraph 1, except those relating to special orders and the data according to § 3 para 2 and 4 are to deliver by the Gesundheit Österreich GmbH on Eudamed.
(2) the data referred to in article 5 are to deliver by the Federal Office for security in the healthcare sector on Eudamed.
(3) the Federal Office for security in the health care sector has in connection with the data according to § 6 in particular the Eudamed to submit:
1. name and address of the sponsor as well as information about the product, such as title and code according to a internationally recognized nomenclature, 3. name and objectives of the clinical trial and 4 fundamental decisions, such as prohibition, suspension of the manufacturer or authorised representative, 2nd or premature termination for safety reasons.
(4) the data referred to in paragraphs 1 to 3, reported from 1 May 2011 until the entry into force of this regulation, shall be transmitted promptly on Eudamed. The data referred to in paragraphs 1 to 3, reported the entry into force of this regulation, shall be transmitted continuously on Eudamed.
(5) the data from manufacturers, agents and products that were reported until April 30, 2011 the Gesundheit Österreich GmbH, are lit by it pursuant to Article 14a 1. a to Directive 93/42/EEC and article 12 paragraph 1, lit. (a) of the directive no later than April 30, 2012 on Eudamed to deliver 98/79/EC;
Form of declarations to the Eudamed
§ 9. All messages on Eudamed must be done in electronic, encrypted form via the Web-based input masks provided by the European Commission. Technically validated data can be uploaded in an automated process using an electronic interface.
Referring to acts of the European Union
§ 10. This regulation is the Commission decision 2010/227/EC on the European database for medical devices (Eudamed), OJ No. L 102 23rd 04th 2010, S. 45, implemented.