Overview

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 medical devices in Germany are exclusive responsibilities of the state authorities.

Germany as a member of the European Union is subject to EU level core regulations for device marketing which are as follows:

  • Council Directive 90/385/EEC for Active Implantable Medical Devices
  • Directive 98/79/EC for In Vitro Diagnostics
  • Council Directive 93/42/EEC, Knows as Medical Device Directive (MDD)

The MDD mandates CE marking be affixed to devices before placing them in market for distribution. In addition, there are some prerequisites for a person responsible to place the device into the market that include:

  • They must have a registered place of business in the Federal Republic of Germany (FRG)
  • They must notify the first placing on the market to the competent authority of the concerned Federal State
  • They must determine a safety officer who is sufficiently reliable and possesses necessary knowledge
  • They must make notifications to Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) via online (www.dimdi.de)

With various authorization bodies involved, foreign manufacturers need to comply with multiple set of regulations in each individual process towards 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.

Germany Market Entry for Medical Devices - Process Flow

Germany Medical Devices Regulatory Services

 

Freyr Expertise

  • European Medical Device Classification
  • ISO 13485 Compliance
  • CE Technical File or Design Dossier Review, Compilation and Submission
  • EU-MDR Transition and Support
  • Clinical Evaluation Reports (CER) for Medical Devices
  • Notification/Registration of Medical devices through DIMDI portal
  • ISO 14971 Risk Management Consulting
  • Medical Device Regulatory Strategy Report
  • Testing Support- Biocompatibility, Electrical Safety and Mechanical & Performance
  • Labeling and GMP Support
  • Post-market Monitoring and Adverse Event Reporting
  • European Authorized Representative Support

Freyr Advantages

  • Successful submissions for varied class of devices ranging from software to sutures
  • Access to local affiliates
  • Dedicated personnel to provide Medical Device and IVD Regulatory support
  • In-country or legal representative support with a cost-effective model
  • Exclusive delivery centre in Germany