Medical Devices Regulatory Services
in Germany

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 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

Germany Medical Device Classification

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.

European Authorized Representative (EAR) Services

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.

Germany Medical Device Registration

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:

  • 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 possess necessary knowledge
  • They must make notifications to Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) via online (www.dimdi.de)

Process flow

Post Approval Device Life Cycle Management

Freyr supports foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

  • Post approval change management - modifications to existing medical device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of ISO 13485:2016 and CE certification
  • Renewal of licenses
  • Liaising between Notified body and the manufacturer

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.

Summary

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

Expertise

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 Notis Online Registration System
  • ISO 14971 Risk Management consultation
  • Medical Device Regulatory strategy report
  • Testing support- biocompatibility, electrical safety, mechanical and performance
  • Labeling and GMP support
  • Post-market monitoring and Adverse Event reporting
  • European Authorized Representative support