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The German Medical Device industry is known for producing high-quality medical equipment. It is the world’s third-largest market and accounts for a huge amount of global demand, annually. BfArM (Federal Institute for Drugs and Medical Devices) is the Regulatory authority implementing the legal framework for the Medical Devices in the country. Monitoring of the device production, market distribution, circulation (including the operation and application), and related implementation of the Medical Devices Act and its legal ordinances concerning Dedical Devices in Germany are exclusive responsibilities of the state authorities.
Regulatory Authority: BfArM (Federal Institute for Drugs and Medical Devices)
Regulation: Medical Device Regulations, 2017
Regulatory Pathway: CE marking followed by Notification
Authorized Representative: European Authorized Representative (EAR) for Non-EU manufacturers
QMS Requirement: ISO 13485:2016
Assessment of Technical Data: Notified Body for CE marking
Validity of License: Unlimited
Submission Format: Paper
Prior to marketing the Medical Devices, either Active Implantable Medical Devices (AIMD) or In-vitro Diagnostic Medical Devices (IVDDM), it is mandatory for the manufacturers to obtain CE certification. In order to affix the CE marking, the market entrant must submit the devices for compliance evaluation with the essential requirements as per the applicable European directives. The European provisions have been transposed into French law in the Public Health Code.
Manufacturers based out of European Union shall appoint a European Authorized Representative (EAR) to market the devices in any of the EU member countries. The EAR, appointed, shall comply with all requirements defined in Medical Device Regulations (EU)2017/745.
The MDD mandates CE marking should be affixed to devices before placing them in the market for distribution. In addition, there are some prerequisites for a person responsible to place the device into the market that include:
Freyr supports foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:
With various authorization bodies involved, foreign manufacturers need to comply with multiple set of regulations in each individual process for device approvals. Obtaining a CE marking and further adhering to state-wise regulations needs extensive Regulatory knowledge. At times, without a proven Regulatory partner, navigating through all the device requirements might be challenging for market entrants. To assist manufacturers, Freyr provides end-to-end Regulatory services to expedite approvals for medical devices.
Type of Device | Risk | QMS Audit | CE Marking | Regulatory Pathway |
Class I |
Low Risk |
N/A |
CE Self-Certification |
Registration |
Class IIa |
Low- Moderate Risk |
ISO 13485:2016 certification |
CE Mark |
Notification |
Class IIb |
Moderate - High Risk |
ISO 13485:2016 certification |
CE Mark |
Notification |
Class III |
High risk |
ISO 13485:2016 certification |
CE Mark |
Notification |
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