EU IVDR Consulting

In 2017, the EU introduced the in Vitro Diagnostic Devices Regulation 2017/746 (IVDR) and forever changed the IVD regulatory framework. Since then, IVD manufacturers, notified bodies (NBs), distributors, and Competent Authorities have been scrambling to make sense of the new requirements and scale their operations to achieve and maintain compliance under the new regulations. Final transition deadlines are approaching and IVD companies need to take action. 

Pure Global provides end-to-end EU IVDR consulting support to EU- and non-EU-based manufacturers seeking CE Marking for IVDs. With more than 15 offices across five continents, we provide global expertise with local regulatory knowledge, ensuring your IVD devices achieve CE Marking efficiently and without unnecessary delays. Our use of AI-driven tools and regulatory data analytics further accelerates the compliance process, giving your company a competitive edge in the EU market.

Subscribe to newsletter
Subscribe to receive our monthly newsletter to your inbox.
By subscribing, you agree to our Terms and Conditions.
Thank you for subscribing!
Oops! Something went wrong while submitting the form.
EU IVDR Information

EU IVDR Classification

Most IVDs were reclassified under the IVDR, which means you will likely face more rigorous conformity assessment requirements. Before you can identify those requirements, you must accurately classify your device according to IVDR implementing and classification rules. We will help you refine your device’s intended purpose, if needed, and assess your device’s classification according to the IVDR.

EU CE Marking for IVDs

At the end of the transition period, all IVDs sold in the EU must bear CE Marking under the IVDR. When your IVD requires IVDR CE Marking will depend on your device’s legacy status and device classification. To ensure compliance by your IVD’s deadline, Pure Global can perform a thorough evaluation of your technical documentation and clinical evidence to assess your IVDR readiness and develop a regulatory strategy for IVDR CE Marking.

EU IVDR PER Performance Evaluation Report

The Performance Evaluation Report (PER) is an essential part of your Technical Documentation for CE Marking that must be updated continuously throughout the product life cycle. It includes individual reports for scientific validity, analytical performance, and clinical performance data, as well as explanations of the methods you used to gather clinical evidence, perform literature searches, etc. We can help you plan your performance evaluation process and collaborate with your team to maintain compliance with performance evaluation requirements.

EU PMPF Post-Market Performance Follow-Up for IVDs

Post-Market Performance Follow-up (PMPF) is a new but critical requirement introduced under the IVDR. PMPF is an ongoing process to collect and evaluate performance and scientific data from the use of your device on the market. PMPF data supports your Performance Evaluation (PE), risk management, and Post-Market Surveillance (PMS) activities. We can help you design a PMPF plan and execute PMPF activities, including PMPF studies, throughout the device life cycle. 

EU Eudamed Medical Device & IVD Registration

All medical device and IVD manufacturers selling in the EU will be required to register their companies and devices in EUDAMED. Device registration comes with maintaining detailed information about your device and compliance with Unique Device Identifier (UDI) requirements. We can help you obtain UDI codes and build EUDAMED registration procedures into your process so you are ready when EUDAMED registration becomes mandatory.

EU MDR and IVDR Post-Market Surveillance (PMS)

Post-Market Surveillance requirements expanded under the EU MDR and EU IVDR. Our team of regulatory professionals specializes in helping medical device manufacturers develop and implement compliant, efficient, and risk-based PMS strategies tailored to their products. We provide hands-on guidance to ensure that your PMS plans, reports, and procedures meet the stringent EU MDR and IVDR requirements.

EU Representative European Authorized Representative for Medical Devices & IVD Companies

If you’re a non-EU manufacturer of medical devices or in-vitro diagnostics (IVDs) looking to sell in Europe, you need a trusted EU Authorized Representative (EU AR) to ensure compliance with the EU MDR and EU IVDR. The EU AR is responsible for regulatory documentation, incident reporting, and ensuring compliance with post-market requirements. With offices throughout Europe staffed by experienced medical device and IVD regulatory professionals, we can act as your regulatory and commercial partner.

CE Mark Notified Body Search and Selection

Finding the right Notified Body can be challenging due to limited availability, long review timelines, and varying expertise across different Notified Bodies. Choosing the wrong Notified Body can result in delays, increased costs, or even non-approval of your product, significantly impacting your market access. With our expert support, you can efficiently identify, evaluate, and engage with the best Notified Body for your device, ensuring a smooth certification process and faster time-to-market.

EU MDR & IVDs PRRC Person Responsible for Regulatory Compliance

Under the EU MDR and IVDR, medical device manufacturers selling in Europe must appoint a Person Responsible for Regulatory Compliance (PRRC) who is responsible for overseeing regulatory compliance, quality management, and post-market surveillance. The PRRC must have a degree in a relevant discipline plus one year of regulatory experience or at least four years of experience in regulatory affairs or quality management for medical devices.

How We Can Help

EU IVDR consulting support to EU- and non-EU-based manufacturers seeking CE Marking for IVDs

With 15 offices across five continents, we provide global expertise with local regulatory knowledge, ensuring your in-vitro diagnostic (IVD) devices achieve CE Marking efficiently and without unnecessary delays.

Frequently
Asked Questions

Can a consultant help us prepare for a Notified Body audit?

Absolutely. Consultants simulate audits, conduct gap analyses, and review documentation through a Notified Body lens so that you're fully prepared for inspection and can respond promptly to any questions.

Do consulting firms provide support beyond the initial certification?

Yes. Leading consulting firms offer full lifecycle support that extends well beyond the initial CE Marking process. Once your device is certified under the IVDR, you’re required to maintain compliance through ongoing activities such as Post-Market Surveillance (PMS), Post-Market Performance Follow-up (PMPF), periodic updates to your Performance Evaluation Report (PER), and continuous updates to your technical documentation. A consulting partner can help you develop and execute a risk-based PMS plan, design and manage PMPF studies, and ensure that new clinical data or literature is properly assessed and integrated into your documentation. They can also assist with periodic safety update reports (PSURs), vigilance reporting, and audit readiness as your product evolves or your portfolio grows.

Do I still need help if my IVD is low risk?

Class A IVDs, which are considered low-risk, are still subject to the full scope of the IVDR’s general obligations. While some may not require Notified Body involvement, they still require technical documentation, risk management, Post-Market Surveillance (PMS), and registration in the EUDAMED database. These steps can be surprisingly complex. A consultant can help ensure nothing is overlooked in the initial conformity assessment preparation and support IVDR compliance throughout the life cycle.

Does IVDR consulting offer value even if we already have an internal regulatory team?

Yes. Consulting firms can supplement the expertise of internal teams by providing strategic oversight, reviewing documentation before submission, managing bottlenecks, and ensuring your interpretations of the regulation align with EU guidance.

Single Process,
Multiple Markets

When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.

Let's Talk,
Anywhere You Are.

Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

Contact us