Law library  /  MPDG  /  Section 15
Medical Devices Implementation Act · Chapter 2 · Notification, placing on the market, putting into service and making available
Section 15

Making custom-made devices available on the market

§ 15 MPDG · Bereitstellen von Sonderanfertigungen auf dem Markt

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

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Custom-made devices may be made available on the market only if

Sonderanfertigungen dürfen nur auf dem Markt bereitgestellt werden, wenn sie

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1. they meet the relevant general safety and performance requirements set out in Annex I to Regulation (EU) 2017/745, and

1. die relevanten grundlegenden Sicherheits- und Leistungsanforderungen des Anhangs I der Verordnung (EU) 2017/745 erfüllen und

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2. the relevant conformity assessment procedures under Article 52(8) and Annex XIII to Regulation (EU) 2017/745 have been carried out.

2. die entsprechenden Konformitätsbewertungsverfahren nach Artikel 52 Absatz 8 und Anhang XIII der Verordnung (EU) 2017/745 durchgeführt wurden.

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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.