Regulatory Authority
Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM – The Federal Institute for Drugs and Medical Devices (BfArM).
Classification
I, IIa, IIb, III
Quality system
ISO 13485:2016
All Medical Devices must bear the CE marking in order to be marketed. Non-EU Manufacturers must appoint an Authorized European Representative.
The person responsible for the Medical Device first marketing with its registered office in Germany must notify the local authority responsible for the relevant Federated State. Furthermore, upon initial marketing, the responsible person must identify the person responsible for the safety and inform the Competent Authority. Notifications must be made online through BfArM website.
Applicant
Non-EU Manufacturers must appoint an Authorized European Representative.
Timeframe and costs
Timeframe: 1 day. There are different fees for the approval of the registration, for any changes to be made and for the possible extension of the certificate.
Validity
The notification to the BfArM has unlimited validity.
Labelling and documentation language
Documentation and labelling shall be provided in German.
Useful information
Each German Federated State (Bundesland) has its own competent Authority for the health sector. The BfArM website is constantly updated in German and English. Like all the Countries of the European Union, Germany will also adopt the New Regulation (EU) 2017/745 on Medical Devices. It is recalled that such Regulation, approved on April 5, 2017, is then entered into force on May 26, 2017. The full implementation of the New Regulation will take place on May 26, 2021.
