Authority for Justice and Consumer Protection

Report commercial handling of medical devices

Prerequisites

Documents required

Please include the following in your ad:

• 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.

Please note

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

• 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.

For CE certification, a procedure to confirm the essential requirements in accordance with the EU legal requirements for medical devices (conformity assessment procedure) must be successfully completed.
Depending on the risk class of the medical device or in vitro diagnostic device, an expert body will be consulted.

Deadlines

Submit the notification before placing the medical devices on the market.

Procedure

Report the commercial handling of medical devices electronically.

• 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.

Processing time

There is no legally prescribed processing time.

Fees

Fees are charged according to the time spent in accordance with the fee schedule for public consumer protection.

Legal remedies

contradiction

Legal basis

• 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