Medical devices; application for a certificate of marketability
For the export of a medical device, a certificate of marketability of the medical device in Germany is required (Freiverkäuflichkeitsbescheinigung).
Description
At the request of the manufacturer or his authorized representative, the competent authority shall issue a certificate of free sale. A certificate of free sale may also be issued for products placed on the market in accordance with Article 120(3) of Regulation (EU) 2017/745. This applies mutatis mutandis to devices that were lawfully placed on the market before 26 May 2021 in accordance with national provisions transposing Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17) and Directive 93/42/EEC and may continue to be made available on the market or put into service until 26 May 2025.
Competent authorities
The competent authority for active medical devices is the Bavarian State Office for Health and Food Safety (LGL).
For non-active medical devices, the following governments are responsible:
- Government of Upper Franconia: responsible for the administrative districts of Upper Palatinate, Upper Franconia, Middle Franconia and Lower Franconia.
- Government of Upper Bavaria: responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia.
Prerequisites
The requirements result from § 10 Medical Device Law Implementation Act (MPDG).
Procedure
The application must be submitted informally by electronic means (e-mail) to the competent authority (see under "Description").
Processing time
The processing time depends on the scope of the documents to be examined.
Required documents
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Proof of the marketability of the medical devices to be exported (declarations of conformity, certificates from a notified body)
If there are several products, it is useful to attach a summary in the form of a text or table file.
Forms
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Status:01.09.2023
Responsible for editing:Bayerisches Staatsministerium für Gesundheit und Pflege
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Form, Bavaria-wide
- Form, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited
If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.