📂 IVDR (2017/746) Compliance Counseling

Are you ready for the new regulations for your in vitro diagnostic medical devices?

The European Union’s new in vitro diagnostic medical device regulation, IVDR (EU) 2017/746, replaces the previous IVDD (98/79/EC) directive and regulates the safety, performance and clinical evidence of devices much more strongly. Due to the increased audit burden and class changes, it is critical that manufacturers fully and promptly comply with the IVDR.

Era Management provides end-to-end consulting services on technical, clinical, and regulatory issues throughout the IVDR compliance process.

Services

  • ›Gap Analysis and Compliance Strategy: Analysis of existing documents in terms of compliance with IVDR and creation of a roadmap.
  • ›Technical File Preparation (Annex II and III): Preparation of technical documents in accordance with new requirements.
  • ›Device Classification and Conformity Pathway Determination: Determining the appropriate certification strategy based on your device's risk class.
  • ›Clinical Performance Studies and PER Preparation: Performance evaluation report (PER), creation of scientific validity, analytical and clinical performance data.
  • ›UDI and EUDAMED Consultancy: Managing product identification and EU system registration processes.
  • ›Quality Management System Integration: Establishment of an IVDR-compliant QMS structure integrated with ISO 13485.
  • ›PRRC (Person Responsible) Process: Structuring the personnel and responsibility structure under Article 15 of the IVDR.
  • ›Notified Body (NB) Process Support: Certification application, question-and-answer processes, and audit preparation.

Correct Product Classification (IVDR Annex VIII)

IVDR offers a much more detailed and stringent classification system than IVDD (Classes A, B, C, and D). These classes are determined by the clinical risk of the device and its impact on public health. Your device's class is crucial in terms of the certification pathway, clinical data requirements, and notified body obligations.

  • ✔Determining the correct class for your device.
  • ✔Evaluation of class promotion situations
  • ✔Borderline product review and guidance support.
  • ✔Planning your compliance strategy according to the device class.

The Importance of IVDR Compliance

  • ›Sustainability and product continuity in the European market.
  • ›Proving the safety and clinical validity of the device.
  • ›Speeding up success and approval processes in audits.
  • ›The advantage of integrating with new systems such as EUDAMED, UDI, and labeling.

✅ Why Era Management?

●IVDR's experienced team of consultants
●A holistic approach across clinical, technical, and regulatory fields.
●Result-oriented support in the certification process.
●Application support based on current MDCG guidelines.

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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