Anzeige des gewerblichen Umgangs mit Medizinprodukten Übermittlung

• Art. 31 VO EU 2017/745 i. in conjunction with § 97 MPDG
• Art. 28 VO EU 2017/746 i. in conjunction with § 97 MPDG
• Announcement according to § 97 paragraph 1 sentence 2 and paragraph 2 of the Medical Devices Law Implementation Act to regulate the transition period until the European database for medical devices is fully functional according to Article 33 of Regulation (EU) 2017/745
• Announcement according to § 96a paragraph 3 and § 97a paragraph 1 sentence 2 and paragraph 2 of the Medical Devices Law Implementation Act to regulate the transition period until the European database for medical devices is fully functional according to Article 33 of Regulation (EU) 2017/745
  and Article 30 of Regulation (EU) 2017/746
• MPDG

• placing medical devices on the market or making them available on the market,
• Reprocess medical devices exclusively for others who are to use them as intended in a sterile or low-germ state,
• placing on the market or making available on the market assembled systems or procedure packs using medical devices, or
• sterilize these or other medical devices for placing on the market.

Please also indicate any subsequent changes to the information or any discontinuation of the product on the market.

• Your company name and address
• the information concerning the common technological characteristics and analytes for 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 as defined in Annex II to Directive 98/79/EC and in vitro diagnostic medical devices for self-testing, all information enabling the identification of those in vitro diagnostic medical devices, the analytical and, where appropriate, diagnostic performance data as defined in Annex I, Section A, No 3 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", the additional statement that it is a "new in vitro diagnostic medical device" must be provided.

• Fill out a registration application on the online service.
• Share your data and send it online.
• The responsible authority will receive your notification.
• The responsible authority will then process your advertisement and release it into the relevant database.
• You will receive feedback about the release of the data.

• the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• the diagnosis, monitoring, treatment, alleviation or compensation of injuries or disabilities,
• the investigation, replacement or modification of anatomy or of a physiological or pathological process or condition,
• contraception or the promotion of conception,
• cleaning, disinfection or sterilization of medical devices or their accessories.

• Notification required for:
• Placing or making available medical devices on the market,
• Reprocessing of medical devices for others that are used in a low-germ or sterile manner,
• Placing on the market or making available assembled systems or procedure packs using medical devices.
• Sterilization of medical devices for placing on the market.
• Subsequent changes to the information or discontinuation of marketing