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 authorised representative, the competent authority shall issue a certificate of free sale. A certificate of free sale may also be issued for devices 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 Devices Implementation Act (MPDG).

Export certificates for in vitro diagnostic medical devices (IVD) will continue to be issued until 25 May 2022 in accordance with Section 34 (1) of the Medical Devices Act (MPG). For IVDs, certain parts of the MPG in the version applicable up to and including 25 May 2021 will apply until 25 May 2022.

The continued applicability of the MPG (also § 34) for IVDs until 25 May 2022 results from § 2 para. 1 sentence 2 no. 1 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

  • 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

  • Prefillable Form, Bavaria-wide: Formloser Antrag (ohne Unterschrift)
    Please note

    This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

Fees

  • The fee is set out in the schedule of costs, tariff no. 7.I.9/6, the expenses (e.g. postal delivery charges) are individual. The costs (fee and expenses) are to be borne by the applicant.

Remedy

Administrative court proceedings; information

Administrative court action

Status: 31.07.2021

Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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