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  • 1.  Compassionate use_Medical Devices_Germany

    Posted 16-Aug-2018 10:33
    ​​Hi Guys,

    Can anyone provide any guidance on compassionate use of Medical Devices in Germany? Is there any guidance document available from the authority on this subject?

    Any guidance is highly appreciated.

    Best regards,
    Meenakshi

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    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
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  • 2.  RE: Compassionate use_Medical Devices_Germany

    Posted 18-Aug-2018 02:17
    i have been ce labeling in Germany for approximately 6 years and there is no guidance on this subject. i checked the DIMDI website and there is no information listed.
    hope this helps
    Ellen

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    Ellen Karges
    VP of Quality Management/Regulatory Compliance
    Germany
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    Original Message


  • 3.  RE: Compassionate use_Medical Devices_Germany

    Posted 19-Aug-2018 03:16
    To my knowledge compassionate use is regulated for drugs only:

    BfArM - Arzneimittel-Härtefallprogramme/ Compassionate Use
    Bfarm remove preview
    BfArM - Arzneimittel-Härtefallprogramme/ Compassionate Use
    Arzneimittel-Härtefallprogramme/Compassionate Use
    View this on Bfarm >


    Otherwise it is the physicians' decision.

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    Prof. Dr. Christian Johner
    Johner Institut GmbH
    Reichenaustr. 1, 78462 Konstanz, Germany
    mail@johner-institut.de
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    Original Message


  • 4.  RE: Compassionate use_Medical Devices_Germany

    Posted 19-Aug-2018 07:44

    Compassionate use is a term, which is to my knowledge, unknown in regulation of medical devices. However, there are exemptions for medical devices, having no conformity assessment: in the Swiss medical device ordinance SR 812.213 it is written in Article 9, that:

    4 The Agency (=Swissmedic) may grant exemptions for placing individual non-conforming medical devices on the market when:

    1. they serve to avert life-threatening conditions or to resolve the permanent impairment of a bodily function;
    2. no conforming device is available for this indication;
    3. they will be used on individual persons only.

    See https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/bw550_00_001d_mbausnahmebewilligungfuermedizinproduktegemaessart.pdf.download.pdf/bw550_00_001e_mbausnahmebewilligungfuermedizinproduktegemaessart.pdf

     

    In the German Medizinproduktegesetz MGP you find in §11

    • 11 Sondervorschriften für das Inverkehrbringen und die Inbetriebnahme
    • Abweichend von den Vorschriften des § 6 Abs. 1 und 2 kann die zuständige Bundesoberbehörde auf begründeten Antrag das erstmalige Inverkehrbringen oder die Inbetriebnahme einzelner Medizinprodukte, bei denen die Verfahren nach Maßgabe der Rechtsverordnung nach § 37 Abs. 1 nicht durchgeführt wurden, in Deutschland befristet zulassen, wenn deren Anwendung im Interesse des Gesundheitsschutzes liegt. Die Zulassung kann auf begründeten Antrag verlängert werden.
    • Medizinprodukt ……………

    See also https://www.bfarm.de/DE/Medizinprodukte/RechtlicherRahmen/inverk/_node.html section Zulassung von Medizinprodukten gemäß § 11 Abs. 1 MPG ("Sonderzulassung")

    Hope this will help you.

    Margit



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    Margit Widmann MD
    Regulatory & Quality Management
    Günsberg
    Switzerland
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    Original Message


  • 5.  RE: Compassionate use_Medical Devices_Germany

    Posted 19-Aug-2018 15:21
    Thank you for this information Margit ... some countries really need to go deep into the regulations to find information.

    Meenakshi: as indicated in the other thread for Europe this is down to individual countries, but the terminology is usually not the same between different countries, i.e. compassionate use, orphan, special purpose, humanitarian use.  Nor is the process or ease of understanding (definitions, applications) as straight forward as the FDA's process.

    As Christian indicated, it is usually up to the physician though to keep your company in low bracket of regulatory risk, I would recommend following the MDR 2017/745 EU Annex III for custom-made devices ... at a minimum.  Following Annex XIII basically you have to gather all the technical documentation (design and manufacture), safety and performance (complete Annex I matrix), clinical use, PMCF, etc.  But calling it a humanitarian device that is CE Marked ... not really anything specific to that beyond country specific regulations.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 6.  RE: Compassionate use_Medical Devices_Germany

    This message was posted by a user wishing to remain anonymous
    Posted 20-Aug-2018 13:44
    This message was posted by a user wishing to remain anonymous

    Hello Meenakshi,

    We have been successful in obtaining compassionate use approval for medical devices in Germany. We have never found any official guidance on how to do this, but we worked with a consultant who had knowledge of the process. Approval is heavily reliant on the physician, and I believe they need to provide a letter explaining why they feel compassionate use is warranted and no other options exist. BfArM did expect that an appropriate level of testing (bench, nonclinical, biocomp, etc) had been conducted, and we had to provide evidence of this. 

    I suggest finding a consultant who can help you, or ask your EU authorized representative if they have experience in this area. 

    Good luck!



    Original Message


  • 7.  RE: Compassionate use_Medical Devices_Germany

    Posted 22-Aug-2018 06:03

    Hi Meenakshi,

    Compassionate use is not specifically addressed in the German law on medical devices (MPG). It is only possible based on constitutionally guaranteed freedom to perform diagnosis and therapy for medical doctors. Medical doctors at the same time have an obligation to treat patients.

    However, Compassionate use may not be misused by researchers to camouflage research projects as a healing attempt to avoid legal regulations.
    A     strictly case-related approach is required.
    If the general gain of knowledge for the science in the primary motive for compassionate use, compassionate use is not possible.
    Compassionate use can only be considered if the doctor's primary aim is to treat an individual person or a limited group of individuals for which standard and approved treatment options are no a suitable option.

    For pharmaceuticals products (drugs) the responsible German authority (BfArM) requires the following conditions to be met in order to allow compassionate use:

    ·       Evidence that patients have a life-threatening or severe disability-causing disease.

    ·       There is evidence that there is no satisfactory alternative treatment option with a medicinal product authorized in the EU.

    ·       There is evidence that the medicinal product in question is either the subject of a marketing authorization application or is the subject of a pending clinical trial.

    Best regards,
    Stefan



    ------------------------------
    Stefan Menzl
    Executive Director Qserve Group Deutschland GmbH
    Germany
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    Original Message


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