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Medical Devices Implementation Act · Chapter 4 · Clinical investigations, performance studies and other clinical investigations
Section 67

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§ 67 MPDG · Informationsaustausch

Medizinprodukterecht-Durchführungsgesetz (MPDG) · German text as of 29 October 2026 · translation edited by Alexander Baranov

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As regards reports received under Article 80(2)(a) of Regulation (EU) 2017/745, Article 76(2)(a) of Regulation (EU) 2017/746 or section 64(1) item 1, the Federal Institute for Drugs and Medical Devices (BfArM) shall inform the authorities competent

Über Meldungen, die nach Artikel 80 Absatz 2 Buchstabe a der Verordnung (EU) 2017/745, Artikel 76 Absatz 2 Buchstabe a der Verordnung (EU) 2017/746 oder § 64 Absatz 1 Nummer 1 eingehen, informiert das Bundesinstitut für Arzneimittel und Medizinprodukte die Behörden, die zuständig sind

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1. for the sponsor or its legal representative,

1. für den Sponsor oder seinen rechtlichen Vertreter,

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2. for the investigation sites and

2. für die Prüfstellen und

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3. for the place of the serious adverse event.

3. für den Ort des schwerwiegenden unerwünschten Ereignisses.

Does § 67 MPDG affect your product?

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Unofficial translation for information only. Only the German text is legally binding. German text: consolidated version from gesetze-im-internet.de, retrieved 29 October 2026. Where German statutes use “soll”, “shall” denotes an obligation that admits exceptions in atypical cases. Not legal advice.