Administrative services A-Z

The registration of manufacturers, importers and authorised representatives of products that comply with Regulation (EU) 2017/745 or Regulation (EU) 2017/746 or that fall under the transitional provisions of Article 120(3) of Regulation (EU) 2017/745 or Article 110(3) of Regulation (EU) 2017/746 is carried out via EUDAMED (Actor Registration) (see point II of the BMG's announcement of 26.05.2021).

The registration of devices that comply with Regulation (EU) 2017/745, as well as systems and treatment units, is carried out in accordance with Section 96 (1) MPDG via the DMIDS at the BfArM (see also point I of the BMG's announcement of 26.05.2021).

The registration of products that comply with Regulation (EU) 2017/746 is carried out in accordance with § 96a paragraph 1 MPDG via the DMIDS at the BfArM (see also point I of the BMG's announcement of 16.05.2022).

The registration of establishments and facilities that reprocess devices that are intended to be low-germ or sterile exclusively for others, or healthcare facilities that reprocess or have reprocessed single-use devices in accordance with Article 17 (3) of Regulation (EU) 2017/745, is carried out in accordance with § 4 (1) MPDG via the DMIDS at the BfArM.

• EU Login (europa.eu)
• Https://www.bfarm.de/DE/Medizinprodukte/Portale/DMIDS/_node.html

Medical devices are instruments, apparatus, devices, software, implants, reagents and materials intended for human use and intended, alone or in combination, to perform one or more of the following purposes:

- the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases,
- the diagnosis, monitoring, treatment, alleviation or compensation of injuries or disabilities,
- the examination, replacement or modification of the anatomy or of a physiological or pathological process or condition
- contraception or promotion- the cleaning, disinfection or sterilization of medical devices or their accessories

In vitro diagnostic medical device means a medical device which, as a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software or system, individually or in combination, is intended by the manufacturer for the in vitro examination of samples derived from the human body, including blood and tissue donations, and is intended solely or principally to provide information on one or more of the following

(a) physiological or pathological processes or conditions;
(b) congenital physical or mental impairments;
(c) predisposition to a particular health condition or disease;
(d) to determine the safety and tolerability of potential consignees;
(e) the likely effect of a treatment or the likely responses to it; or
(f) for the definition or monitoring of therapeutic measures.
Sample containers are considered to be in vitro diagnostic medical devices;

 
If you are based in Germany and
- place medical devices or in vitro diagnostic medical devices on the market or make them available on the market,
- reprocess medical devices exclusively for others that are intended to be used in a low-germ or sterile manner,
- place on the market or make available on the market systems or procedure packs assembled using medical devices, or
- sterilize these or other medical devices for placing on the market,
you must notify the LAVG of this before commencing the activity, stating your address.

Before commencing activities, you as the manufacturer must indicate the name and description of the medical devices concerned when displaying composite systems and procedure packs. If you, as a manufacturer, want to sterilize these or other medical devices before they are used, you must also indicate the designation before starting the activity.


You must notify us immediately of any subsequent changes to the information and a cessation of placing on the market. The competent authority is the LAVG.

• For medical devices placed on the market in Germany, the bearing of a CE marking is mandatory.
• The prerequisite for CE certification is the successful completion of a procedure to confirm the essential requirements in accordance with the EU legal requirements for medical devices (conformity assessment procedure).
• Depending on the risk class of the medical device, the involvement of a notified body may be necessary.

Information on possible required data can be found in the instructions on the website of the DMIDS or EUDAMED.

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Before placing medical devices on the market or making them available on the market, display them online:

- Fill out your online application in the DMIDS or EUDAMED.
- Share your data and send it online.
- The LAVG will be automatically informed about your ad.
- The LAVG finally processes your ad and releases it in the appropriate database.
- You will automatically receive feedback from the LAVG about the release of the data.

Notification period: The notification must be made before the start of the activity.

State Office for Occupational Safety, Consumer Protection and Health (LAVG)

Department of Health, Department G4

• Art. 31 Regulation (EU) 2017/745 in conjunction with § 97 MPDG
• Art. 28 Regulation (EU) 2017/746 in conjunction with § 97 MPDG
• §97 Medical Devices Law Implementation Act (MPDG)
• Announcement pursuant to Section 97 (1) sentence 2 and (2) of the Medical Devices Law Implementation Act regulating the transitional period until the European database for medical devices is fully operational in accordance with Article 33 of Regulation (EU) 2017/745 of 26 May 2021
• Announcement pursuant to § 96a (3) and § 97a (1) sentence 2 and (2) of the Medical Devices Law Implementation Act regulating the transitional period until the European database for medical devices is fully operational in accordance with Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746 of 16 May 2022

- on the internal website of the BfArM information on:

• legal framework
• Notification and reporting channels for manufacturers, clinical trials and incidents
• competent authorities in Germany and notified bodies in the European Union

• Website of the BfArM

Ministry of Social Affairs, Health, Integration and Consumer Protection of the State of Brandenburg