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EU 2017/746 IVDR Consultants
We are IVDR Consultants, and it’s one of I3CGLOBAL’s super specialties. We cover all risk classes of IVD products. We have great experience in preparing technical documentation and performance evaluation reports (PERs) that comply with the IVDR 2017/746 regulation. We have assisted many manufacturers in becoming certified under IVDD 93/42/EEC regulation, which was in place before the new regulatory framework was put into place.
The new IVDR 2017/746, In Vitro Diagnostic Regulation in Europe, puts stringent regulations on IVD manufacturers who sell in Europe. Is your current technical documentation adequate to meet the new requirements, especially clinical data, PER, and PMS requirements
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Responsibilities of IVDR Consultants
IVDR consultants play a crucial role in helping manufacturers and other stakeholders navigate the complex landscape of new IVDR 2017/746 compliance. This regulation, which came into effect in May 2022, has significantly changed the regulatory requirements for in vitro diagnostic medical devices (IVDs) in the European Union (EU).
Consultants provide various technical services to ensure that their clients meet these requirements and can continue to market their products in the EU. Some of the key roles include:
- Due diligence services
- Confirmation of Device Class
- Guidance and preparation of the Technical Documentation File
- Review of Device Intended Use
- Review of design files and approval records
- Review and guidance for risk management
- Development of a performance evaluation plan and report documentation
- Post-market surveillance plans and maintenance activities
- Analytical performance plan and reporting
- Scientific validity assessment
- Support the Post-Market Performance Follow-up (PMPF) Plan,
- Documenting General Safety and Performance Requirements (GSPR)
- Review of Verification and Validation Reports
- Notified body submission, technical review response, and file updates
Having a QMS certified to ISO 13485 and data security certified to ISO 27001 demonstrates our commitment to quality and security in the service operations. Being responsive to technical emails within 24 hours is also commendable, as it shows that we prioritize customer service and timely communication.
Overall, IVDR consultants play a critical role in helping manufacturers navigate and document the complex regulatory requirements and ensure the Notified Body approval on time, thereby enabling them to continue marketing their products in the EU territory.
Do you have an IVDR transition strategy in place? Don’t be concerned. We are IVDR consultants and regulatory experts! I3CGLOBAL and its team of professionals possess the qualifications and experience to undertake risk-class IVDR projects from any corner of the globe.
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The Cost for IVDR Consulting
The cost of IVDR consulting can differ greatly, influenced by various factors including the project’s scope, the novelty or risk class of the IVD, the complexity of their intended use, and the range of device models and variants.
Best pricing offers from I3CGLOBAL. We take up all kinds of IVD Device CE Marking. We have associated with multiple labs for performance Evaluation.
Frequently Asked Questions
Do you provide assurance of CE Certification?
How long the IVDR Technical Documentation?
The timeline depends upon the prompt delivery of product technical and scientific information to our consultants. Typically, this process takes around 3-4 months
Very useful for small and medium size medical device manufactures
