Team Elexes 
Elexes Team 
EU IVDR Consulting Services
When it comes to medical device manufacturers developing IVDs, it is mandatory for manufacturers to comply with the European Union In Vitro Diagnostic Regulations (EU IVDR) 2107/746 if they wish to market their devices in the European market.
Luckily, Elexes has experts who have years of experience in helping medical device manufacturers and companies meet IVDR regulations. Right from managing the required submissions to handling any and all Health Authority's (HA) queries, our experts will take care of it all for you.
Who Needs UKCA Marking for Medical Devices?
The European In Vitro Diagnostic Regulation (EU IVDR) was created with the goal of providing a new regulatory framework for bringing IVDs to the European market, replacing the previous Directive 98/79/EC.
As an EU regulation, it applies directly to all EU Member States and EFTA countries without requiring national transposition into law.
At Elexes, we have excellent EU IVDR experts who offer tailored EU IVDR compliance and consulting services. Our expertise ensures that manufacturers achieve seamless compliance with the IVDR requirements and obtain CE marking for their in vitro diagnostic devices, enabling smooth market access across Europe.
The IVDR Regulation | Transition Timeline
It was on May 26, 2022, when the EU IVDR went through a significant
change with respect to the regulatory framework for IVDs.
Key aspects of the IVDR transition include:
⦿ Nearly all IVDs entering the European market now require a Notified Body (NB) review and CE marking certification as part of the approval process.
⦿ Manufacturers must align with the updated IVDR classification and thoroughly review their technical documentation to ensure successful registration and CE marking.
⦿ Compliance requirements vary by the IVD's risk class but generally include:
Preparing technical files in accordance with Regulation EU 2017/746.
- Developing a Performance Evaluation Report (PER) for all IVDs.
- Conducting Post-Market Performance Follow-up (PMPF) as specified in Annex XIII, Part B of the IVDR.
- Adhering to vigilance reporting guidelines outlined in Article 82 of the IVDR.
At Elexes, we assist IVD manufacturers in:
⦿ Conducting comprehensive scientific literature reviews
⦿ Preparing PERs for IVDR compliance
⦿ Post-Market Surveillance (PMS)
⦿ PMPF support
⦿ ISO 13485 certification
⦿ Seamlessly integrating these elements into the manufacturer's quality management system (QMS), ensuring EU IVDR regulatory compliance.
Our IVDR Compliance Services
At Elexes, we provide end-to-end solutions to guide manufacturers
through the transition to EU IVDR compliance, including:
Transition Planning
Comprehensive roadmap to achieve IVDR compliance.
Technical Review and Gap Analysis
Detailed evaluation of the General Safety and Performance Requirements (GSPR) to identify and address gaps.
Technical File Compilation
Assistance in creating a complete and compliant technical file as per IVDR requirements.
Scientific Validity Reports
Development of robust reports using literature reviews or in-house data.
Clinical Performance Reports
Preparation of evidence-based reports to demonstrate device performance.
Performance Evaluation Reports
Compilation of clinical evidence in line with IVDR expectations.
Post-Market Performance Follow-Up (PMPF)
Drafting and review of PMPF protocols and reports to ensure continued compliance.
Post-Market Surveillance (PMS)
Creation and maintenance of PMS protocols and reports as part of the quality management system.
Our Expertise
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
Local Regulatory Certification
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
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Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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MD Blackrock Pharma, England
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CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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