AUSWIRKUNGEN VON BEHÖRDLICHEN REGULIERUNGEN AUF DIE DOKUMENTATION

Transkript

1 AUSWIRKUNGEN VON BEHÖRDLICHEN REGULIERUNGEN AUF DIE DOKUMENTATION Medizintechnik und Dokumentation 1

2 AGENDA Aktuelle Regelungen Abgrenzung FDA/EMA Vorschlag zur Medical Device Regulation Folgen für die Dokumentation Fragen

3 AKTUELLE REGELUNGEN allgemein o rechtliche Regelungen der verschiedenen Wirtschaftsräume national, europäisch, US-amerikanisch,... z.b. Medizinproduktegesetz o Normenreihen und Richtlinien Datensicherheit Compliance Quality Management

4 AKTUELLE REGELUNGEN Andere Regularien innerhalb der EU o Richtlinie 85/374/EWG => Produkthaftungsgesetz EU-Richtline d.h. Umsetzung in nationales Recht notwendig 2: Produkt im Sinne dieses Gesetzes ist jede bewegliche Sache, auch wenn sie einen Teil einer anderen beweglichen Sache oder einer unbeweglichen Sache bildet, sowie Elektrizität. 3: (1) Ein Produkt hat einen Fehler, wenn es nicht die Sicherheit bietet, die unter Berücksichtigung aller Umstände, insbesondere a) seiner Darbietung, b) des Gebrauchs, mit dem billigerweise gerechnet werden kann,..

5 AKTUELLE REGELUNGEN Andere Regularien innerhalb der EU o Richtlinie 2006/42/EG => Maschinenrichtlinie EU-Richtline d.h. Umsetzung in nationales Recht notwendig Gilt nicht für medizinische Maschinen! Jeder Maschine muss eine Betriebsanleitung in der oder den Amtssprachen der Gemeinschaft des Mitgliedstaats beiliegen, in dem die Maschine in Verkehr gebracht und/oder in Betrieb genommen wird. Die der Maschine beiliegende Betriebsanleitung muss eine Originalbetriebsanleitung oder eine Übersetzung der Originalbetriebsanleitung sein; im letzteren Fall ist der Übersetzung die Originalbetriebsanleitung beizufügen. Entsprechend für Montageanleitung

6 AKTUELLE REGELUNGEN Andere Regularien innerhalb der EU o Verordnung 1907/2006/EU REACH EU-Verordnung d.h. gilt direkt Gilt nicht für medizinische Produkte Bekannt als Chemikalienrichtlinie Technisches Dossier Expositionsbericht Stoffsicherheitsbericht

7 AKTUELLE REGELUNGEN Andere Regularien innerhalb der EU o Verordnung 726/2004 EU EU-Verordung Zulassungsverordnung für centralised procedure bei Medikamenten Summary of product characteristics = Fachinformation Labelling Dokumente = Verpackung Produkt information leaflet = Beipackzettel In Landessprachen PIL soll readable sein

8 AKTUELLE REGELUNGEN FDA Definition eines Medical Devices : "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

9 AKTUELLE REGELUNGEN EMA A device is: Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

10 EMA

11 RECHTSFORM Rechtsform NICHT DIRECTIVE, sondern REGULATION! direkt in allen EU-Ländern geltende Form, die KEINER Umsetzung in nationales Recht bedarf gilt nach Beschluss unmittelbar! REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

12 Festlegung der Dokumentation Bisheriger Text Keine Entsprechung Text im Vorschlag zur Key documents for the manufacturer to demonstrate compliance with the legal requirements are the technical documentation and the EU declaration of conformity to be drawn up in respect of devices placed on the market. Their minimum contents are laid down in Annexes II and III.

13 Benannte Stellen werden kontrolliert Bisheriger Text Text im Vorschlag zur In the case of class IIa and IIb devices, the notified body checks the quality management system and, for representative samples, the technical documentation

14 NEU! Bisheriger Text????? Folgerungen aus dem Brustimplantateskandal Text im Vorschlag zur Where there is a need to address public health concerns, the Commission, after having consulted the MDCG and the MDAC, the commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post-market clinical follow-up set out in Annex XIII.

15 Hersteller ist verpflichtet Bisheriger Text The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorized representative established in the Community must make this documentation, including the declaration of conformity, available to the national authorities... Text im Vorschlag zur Manufacturers shall draw up the technical documentation which shall allow assessment of the conformity of the device with the requirements of this Regulation. The technical documentation shall include the elements set out in Annex II. KEIN Abwälzen auf Distributoren möglich!

16 Aufbewahrungsfristen verlängert Bisheriger Text Aufbewahrungsfrist: 5 Jahre Datenmengen Text im Vorschlag zur For a period at least equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 10 years from the date of product release by the manufacturer, keep at the disposal of the competent authorities: Where the technical documentation is voluminous or held in different locations, the manufacturer shall provide, upon request by a competent authority, a summary technical documentation (STED) and grant access to the full technical documentation upon request.

17 acceptable easily understood Bisheriger Text The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body. Text im Vorschlag zur Manufacturers shall, in response to a reasoned request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. READABILITY!?

18 Life cycle management Bisheriger Text Text im Vorschlag zur technical documentation permanent immediate access to the necessary documentation in one of the official Union languages. => 2 synchrone Aufbewahrungsorte der jeweils aktuellen Dokumentation??

19 Verpflichtung des Herstellers Bisheriger Text Text im Vorschlag zur Before placing a device on the market importers shall ensure the following:. (c) that the EU declaration of conformity and the technical documentation has been drawn up by the manufacturer

20 Qualified person Bisheriger Text Text im Vorschlag zur The investigations must be performed under the responsibility of a medical practitioner or another authorized qualified person in an appropriate environment. The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device. The person responsible for regulatory compliance shall at least be responsible for ensuring the following matters:: (a) that the conformity of the devices is appropriately assessed before a batch is released; (b) that the technical documentation and the declaration of conformity are drawn up and kept up-to-date;

21 Ständig in allen Sprachen! Bisheriger Text Aktualisiert in allen Sprachen! Text im Vorschlag zur specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be translated into the official Union language or languages required by the Member State(s) in which the device is made available.

22 Vollständigkeit Bisheriger Text Safety report! READABILITY! Text im Vorschlag zur Report of safety and clinical performance 1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw a report on the safety and clinical performance of the device based on the full information collected during the clinical investigation. The manufacturer shall also a draw up a summary of that report. It shall be written in a way in a way that is easy for a lay person to understand in the official language(s) of the country where the medical device is made available on the market.

23 Mehrere Sprachen Bisheriger Text Im Fall der Prüfung muss alles auf Anfrage in mehreren Sprachen vorliegen! Text im Vorschlag zur The national authority responsible for notified bodies shall submit its assessment report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. Upon request by the Commission, those documents shall be submitted by the authority in up to three official Union languages.

24 Studien Teil der Dokumentation Bisheriger Text Die Klinischen Studien und Ergebnisse müssen in die Technische Dokumentation eingehen! Text im Vorschlag zur The clinical evaluation and its outcome shall be documented in a clinical evaluation report referred to in Section 6 of Part A of Annex XIII which shall be included or fully referenced in the technical documentation referred to in Annex II relating to the device concerned.

25 Dokumentation ist geregelt Bisheriger Text Annex II = Tech. Dok. Sprachen für alle Länder der EU, in denen die Vermarktung angestrebt wird Text im Vorschlag zur INFORMATION SUPPLIED BY THE MANUFACTURER (a) a complete set of the label(s) on the device and on its packaging; the instructions for use; (b) a list of the language variants for the Member States where the device is envisaged to be marketed.

26 Verständlichkeit Bisheriger Text READABILITY!? Sprachen können durch den EU-Staat festgelegt werden. Text im Vorschlag zur Manufacturers shall ensure that the device is accompanied by the information to be supplied in accordance with Section 19 of Annex I in an official Union language which can be easily understood by the intended user or patient. The language(s) of the information to be supplied by the manufacturer may be determined by the law of the Member State where the device is made available to the user or patient.

27 UDI Bisheriger Text UDI soll global werden! Text im Vorschlag zur For devices, other than custom-made and investigational devices, a single system for Unique Device Identification (UDI) shall be put in place in the Union. The UDI system shall allow the identification and traceability of devices, be coherent if possible with the global regulatory approach for UDI in medical devices, and shall consist of the following:

28 Was bedeutet das für die Dokumentation (I) Für Intended User gelten gleiche Regeln wie für den Endkunden! Aber natürlich auf dem jeweiligen Sprachniveau Auch die Zulassungsbehörden werden sprachlich gleichgestellt!

29 Was bedeutet das für die Dokumentation (II) Derzeit existieren im Rahmen der EU-Regelungen KEINE Guidances für Readability, sondern nur für den Bereich der FDA bzw. artverwandt für das EU-Pharmalabelling. Die Wortlaute easily to understand legen eine solche zukünftige Regelung für die Zukunft nahe.

30 Was bedeutet das für die Dokumentation (III) Synchrone Datenhaltung bei der Zulassungsbehörde und dem Hersteller: => Life cycle Problematik?? Immediate and permanent access Klinische Studienergebnisse sind Teil der technischen Dokumentation und unterliegen damit den gleichen gesetzlichen Grundlagen Ist ein Unterschied zwischen referenzierten Studien und eingebundenen Studien zu machen?

31 FRAGEN?

32 33