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 requirements.
EC 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.
