Medical Product Reporting Regulation

Original Language Title: Medizinproduktemeldeverordnung

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261. Regulation of the Federal Minister of Health on notifications from manufacturers of medical devices or their authorised representatives, notifications of inspection, monitoring and certification bodies and of notified bodies, notifications of incidents and Clinical trials and notifications to the European Medical Devices Database (Medical Devices Ordinance)

On the basis of § § 66, 67 (7) and 70 (5) of the Medical Devices Act-MPG, BGBl. No. 657/1996, as last amended by the Federal Law BGBl. I n ° 143/2009, shall be:

Scope

§ 1. (1) This Regulation shall apply to:

1.

Notifications from manufacturers or their authorised representatives, who for the first time in the The scope of the European Economic Area (EEA) to be placed on the market and domestiated ,

2.

Notifications from manufacturers of custom-made products for the first time in the Scope of the EEA are established in the territory of the European Economic Area,

3.

Notifications by natural or legal persons, the medical devices according to § 33 (1) MPG, or sterilize according to § 34 MPG, and have its registered office in Germany,

4.

Notifications of bodies, bodies or persons, the testing, monitoring or monitoring Certification activities in accordance with the Medical Devices Act (Medical Devices Act) ,

5.

Notifications from notified bodies,

6.

Notifications of clinical trials and performance assessment tests,

7.

notifications of incidents and

8.

the procedure of data exchange with Eudamed.

(2) Health Österreich GmbH shall have a register which shall be used for the collection of notifications in accordance with paragraph 1 Z 1 to 5.

Definitions

§ 2. For the purposes of this Regulation:

1.

"Eudamed": the European database of medical devices in accordance with the Commission's decision (2010/227/EU) of 19. 04. 2010: L No 102, 23. 04. 2010, S 45);

2.

"Register" means the Register of Medical Devices, which is run by Health Österreich GmbH;

3.

"notified body" means a body according to § 2 para. 16 MPG.

News to the health of Austria GmbH

§ 3. (1) Manufacturers or their authorised agents pursuant to Article 1 (1) (1) (1), manufacturer of special orders pursuant to § 1 (1) (2) (2), and natural or legal persons pursuant to § 1 (1) (1) (3) shall apply to products covered by Directives 93 /42/EEC and 93 /42/EEC 90 /385/EEC, before taking up its duties to health Austria GmbH in particular, to report:

1.

company name or name, address and details of the contact person of the manufacturer or of the authorised representative,

2.

in the case of authorised representative of the manufacturer: company name or name, address and particulars of the contact person of the foreign producer,

3.

Type of activity (type of notification),

4.

Name, telephone number and email of the security officer,

5.

Product name or product or, if not available, general name (generic name),

6.

Code of an internationally recognized nomenclature for medical devices,

7.

Type,

8.

Category of the medical device,

9.

Type of medical device and

10.

Information on professional or industrial authorization.

(2) In the case of products falling under Directive 98 /79/EC, manufacturers or their authorised agents pursuant to Article 1 (1) (1) (1) (Z) 1 shall, before commending their activities, be subject to the health of Austria GmbH in addition to those already under subsection 1 (1) (1) to (7) and (10) , in particular:

1.

IVD classification,

2.

Indication of whether the product is a new product in accordance with Directive 98 /79/EC,

3.

Conformity assessment by the notified body for IVD referred to in Annex II to Directive 98 /79/EC or IVD for its own use,

4.

Conformity with the common technical specifications for IVD referred to in Annex II, List A of Directive 98 /79/EC and

5.

where appropriate, results of the performance evaluation.

(3) In accordance with Section 1 (1) (4) of the Z 4, bodies, institutions or persons shall, before taking up their duties, to report in particular to Österreich GmbH:

1.

Company name or name, address and contact details,

2.

the nature of the activity,

3.

Information on professional or industrial authorization,

4.

Medical product categories and

5.

whether it is an accredited body in accordance with § 90 (2) of the MPG.

(4) Named bodies shall have information relating to certificates issued in accordance with the procedures laid down in Annexes 2 to 5 to Directive 90 /385/EEC, Annexes II to VII to Directive 93 /42/EEC and Annexes III to VII to Directive 98 /79/EC, amended, supplemented, suspended, withdrawn or refused to report to Health Austria GmbH. This notification shall be made once a month and shall contain in particular:

1.

Number and type of certificate,

2.

Date of issue,

3.

End of validity,

4.

the number of the notified body,

5.

company name or name, address and details of the contact person of the manufacturer or of the authorised representative,

6.

Description: general description of validity,

7.

Product details (e.g. B. product name or product or, if not available, general name, generic name) and

8.

Status and, where appropriate, reasons for the decision.

Form of notifications to health Austria GmbH

§ 4. (1) Notifications according to § 3 (1) to (3) shall be made online by means of a web-based input mask to the register. Notifications pursuant to § 3 (4) shall be made electronically by means of a form to be published on the website of health Austria GmbH. Health Österreich GmbH has to enter data in the register according to § 3 (4).

(2) The reporting persons according to § 3 (1) to (3) are responsible for the correctness and completeness of their reports.

(3) The notifiers according to § 3 shall immediately notify any subsequent changes, corrections or additions to the transmitted data.

(4) Health Österreich GmbH has data security measures in accordance with § § 14 ff Data Protection Act 2000, BGBl. I n ° 165/1999, as last amended by the Federal Law BGBl. I No 135/2009.

Reports to the Federal Office for Health Security

Incidents

§ 5. (1) members of a statutory health professional, professional who is authorised to operate or to use a medical device, head of relevant testing, monitoring and certification bodies and technical Medical safety officers of hospitals have incidents in medical devices of Directives 90 /385/EEC, 93 /42/EEC and 98 /79/EC, 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/patient, of a user/user, or of a third party, or who have 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,

that have become known to them as a result of their professional activities, to report immediately to the Federal Office for Health Security and to communicate all the observations and data that can be of importance for medical product safety.

(2) All natural or legal persons who place medical products on the market for the first time in the EEA and those establishments, facilities or persons who place medical devices on the market shall have the incidents referred to in paragraph 1 above and beyond that. 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 instructions for use

Report to the Federal Office for Safety in Health Care immediately.

Clinical trials and performance assessment tests

§ 6. Reports of clinical trials or performance assessment tests and reports on their conclusion according to § 40 MPG, notifications of changes to the test plan in accordance with § 40a MPG as well as reports of serious adverse events according to § 42 para. In the case of products of Directives 90 /385/EEC, 93 /42/EEC and 98 /79/EC, 8 MPG have to be made to the Federal Office for Safety in Health.

Form of notifications sent to the Federal Office for Health Security

§ 7. (1) The notifications pursuant to § § 5 and 6 shall be made electronically by means of notification forms, which are to be published on the website of the Federal Office for Safety in the Health Care of the Federal Office for Health and Safety.

(2) In the notification forms according to paragraph 1, no personal data may be included with the exception of information about reporting persons or institutions.

Reports to Eudamed

§ 8. (1) The data according to § 3 (1), with the exception of those relating to special orders, and the data in accordance with § 3 (2) and (4) shall be transmitted by the Austrian health authorities to Eudamed.

(2) The data in accordance with § 5 shall be transmitted to Eudamed by the Federal Office for Safety in Health.

(3) The Federal Office for Health Security has, in connection with the data in accordance with § 6, in particular to transmit the following to Eudamed:

1.

the name and address of the sponsor and of the manufacturer or authorised representative,

2.

information on the product, such as designation and code, in accordance with an internationally recognised nomenclature;

3.

the name and objectives of the clinical trial; and

4.

fundamental decisions, such as under-sawing, suspension or premature termination for security reasons.

(4) The data referred to in paragraphs 1 to 3, which have been reported as from 1 May 2011 until the entry into force of this Regulation, shall be transmitted immediately to Eudamed. The data referred to in paragraphs 1 to 3, which shall be reported from the date of entry into force of this Regulation, shall be sent to Eudamed on an ongoing basis.

(5) The data of manufacturers, authorised agents and of products which have been reported to health Austria GmbH until 30 April 2011 shall be submitted by the same pursuant to Article 14a (1) (1) (1) (1). (a) Directive 93 /42/EEC and Article 12 (1) (lit). a Directive 98 /79/EC to be sent to Eudamed by 30 April 2012 at the latest.

Form of notifications to Eudamed

§ 9. All notifications to Eudamed have to be made in electronic, encrypted form via the web-based input masks made available by the European Commission. Technically validated data can also be uploaded via an electronic interface in an automated process.

References to acts of the European Union

§ 10. This Regulation lays down the Commission Decision 2010 /227/EU on the European Database for Medical Devices (Eudamed), OJ L 327, 28.2.2010, p. No. OJ No L 102, 23. 04. 2010, p. 45.

Stöger