📂 Class III Pharmaceutical Devices and DMF Consulting

Regulatory and File Preparation Support for Your Medicinal Devices Containing Medicines (MDR Annex VIII, Rule 14 & Article 117)

📌 Quick Facts Box:
  • 🔹 Does your device contain a medication that has a systemic effect?
  • 🔹 Is the pharmaceutical substance an integral part of the device?
  • 🔹 Is a consultation procedure required from the competent authority during the approval process?

If your answer is “yes,” your product is likely a Class III medicinal device containing medication, which falls under Rule 14 of the MDR. Standard technical file preparation may be insufficient for these devices. Under MDR 2017/745, medical devices that deliver or administer a drug in a way that produces a systemic effect are classified as Class III under Rule 14 and are subject to both medical device and drug regulations.

Era Management offers regulatory compliance strategy development, technical file preparation, and DMF (Drug Master File) support for your pharmaceutical medical devices.

Our Scope of Services

  • ›Product class verification under Rule 14 of Annex VIII of the MDR.
  • ›Establishing a regulatory strategy regarding drug content (MD–MP borderline)
  • ›EMA or national authority consultation procedure support
  • ›Preparation of necessary pharmaceutical quality and safety data for the drug component.
  • ›Preparation or procurement of the DMF (Drug Master File)
  • ›Managing collaboration processes with the manufacturer/supplier of the active substance.
  • ›Integration of drug-related sections into the technical file (Annexes II and III).
  • ›Communication management with approved bodies and competent authorities.

DMF (Drug Master File) Support

For drug-containing devices, data on the quality and safety of the active ingredient must be presented in a DMF (or equivalent data pack). We:

  • •We enable the use of an existing DMF in the appropriate format.
  • •If it's missing, we'll prepare a new DMF on your behalf or coordinate with the manufacturer.
  • •We manage confidential information sharing processes (LoA, restricted access partitions, etc.).

Why is this service important?

  • • Drug-assisted devices are classified in the highest risk category under the MDR.
  • • The competent authority consultation process (Article 117) complicates the product approval process.
  • • Delay in the approval process due to incorrect or incomplete filing.
  • • The difficulties of preparing a technical file without sufficient knowledge of pharmaceutical regulations.

✅ Why Era Management?

●One of the rare consulting firms that takes a holistic approach to medical device and drug regulations.
●Expert team familiar with DMF structure and pharmaceutical data requirements.
●Strategic technical file management specific to CE certification processes.
●Consultant team experienced in communication with approved bodies and authorities.

📞 Contact Us Now!

➡ Does your product fall under Rule 14?

➡ Do you need to prepare for the consultation process?

➡ What to do if there is no DMF? Consult with our experts to create a strategy tailored to your needs.

Frequently Asked Questions

We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.

Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.

The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.

Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.

We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.

Get More Information

For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21

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