Notification of commercial handling of medical devices Transmission

If you are based in Germany and place medical devices on the market or make them available on the market, you must first report this to the State Office for Occupational Safety, Consumer Protection and Health (LAVG).

Medical devices are instruments, apparatus, devices, software, implants, reagents and materials intended for human use and which, alone or in combination, are intended to fulfil 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 alteration of the anatomy or of a physiological or pathological process or condition,
- the prevention or promotion of cleaning, disinfection or sterilisation of medical devices or their accessories



 
If you are based in Germany and
- place medical devices on the market or make them available on the market,
- prepare medical devices exclusively for others who are intended to be used with low germs or sterile,
- place on the market or make available on the market on the market systems or treatment units assembled using medical devices, or
- sterilise these or other medical devices for placing on the market,
you must notify the LAVG of this before commenceing the activity, stating your address.





Before starting the activity, you as a manufacturer must indicate the name and description of the medical devices concerned when displaying composite systems and treatment units. If you as a manufacturer want to sterilize these or other medical devices before their use, you must also indicate the name before starting the activity.

If you as the manufacturer or its authorised representative have your registered office in Germany and place in vitro diagnostic medical devices on the market for the first time, please indicate to the LAVG before commencing the activity:
- the information relating to common technological characteristics and analytes relating to reagents, medical devices containing reagents and calibration and control materials and, in the case of other in vitro diagnostic medical devices, the appropriate information,
- in the case of in vitro diagnostic medical devices listed in Annex II to Directive 98/79/EC and in vitro diagnostic medical devices for self-testing, all the information enabling the identification of those in vitro diagnostic medical devices, the analytical and, where appropriate, diagnostic performance data referred to in point 3 of Section A of Annex I to Directive 98/79/EC, the results of the performance evaluation and information on certificates,
- in the case of a 'new in vitro diagnostic medical device', an additional indication that it is a 'new in vitro diagnostic medical device'.

Subsequent changes to the information as well as a cessation of marketing must be reported immediately. The competent authority is the LAVG.






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

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

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

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

Related Links

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

Preconditions

  • For medical devices placed on the market in Germany, the wearing of a CE marking is mandatory.
  • A prerequisite for CE certification is the successful completion of a procedure for confirming 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 required.

Related Links

  • Art. 31 VO EU 2017/745 in the form of V.m. § 97 MPDG MDR
  • MPDG
  • Announcement pursuant to § 97 paragraph 1 sentence 2 and paragraph 2 of the Medical Devices Law Implementing Act on the regulation of the transitional period until the full functionality of the European Database for Medical Devices according to Article 33 of Regulation (EU) 2017/745
  • MPG

- on the internal page of the BfArM information on:

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

Related Links

  • Website of the BfArM

Before you place medical devices on the market or make them available on the market, display them online:

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



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

Last update or date of publication
01.12.2021