EU MDR Classification
Conformity assessment requirements under the MDR are determined by device classification. Whether your conformity assessment route requires notified body involvement, the scope of your clinical evidence and evaluation, and more will be driven by the risk profile of your device. The MDR brought devices and products that were not regulated under the MDD into its scope. Some devices were reclassified under the MDR, so it’s important to perform a classification assessment, even if you previously obtained CE Marking under the MDD. We can help you determine your device’s risk classification under the MDR so you can determine a conformity assessment strategy.
EU CE Marking for Medical Devices
Devices that are new to the EU market are expected to obtain CE Marking under the MDR. However, some legacy devices with current CE certificates are still operating under the transitional provisions. Pure Global’s MDR experts can prepare you for your MDR notified body audit, even if it’s your first time pursuing CE Marking. With extensive experience drafting EU Technical Documentation, as well as deep familiarity with clinical evaluation and clinical evidence requirements, risk management, and quality management system implementation, we can assess your MDR readiness and facilitate the CE Marking process.
EU MDR CER Clinical Evaluation Report
Clinical evaluation is a systematic, continuous process of collecting and analyzing clinical data about your medical device to ensure the ongoing safety and performance of the device according to its intended purpose. The Clinical Evaluation Report (CER) is part of your Technical Documentation in which the data, outcomes, and conclusions from your clinical evaluation are documented. The CER is a living document that should be updated throughout the product life cycle and critical component of pre-market conformity and ongoing compliance in the EU. With a team of clinical experts and evaluators, Pure Global can help you plan your clinical evaluation process, document your outcomes, and train your team to maintain your CER.
EU PMCF Post-Market Clinical Follow-Up for medical devices
Post-Market Clinical Follow-up (PMCF) is a new requirement introduced under the MDR. PMCF is an ongoing process to collect and evaluate clinical, performance, and scientific data from the use of your device on the market. PMCF data supports your Clinical Evaluation (CE), risk management, and Post-Market Surveillance (PMS) activities. We can help you design a PMCF plan and execute PMCF activities, including PMCF studies, throughout the device life cycle.
EU EUDAMED Medical Device & IVD Registration
Manufacturers of medical devices and in-vitro diagnostics (IVDs) looking to sell in the European Union must register their products and company details in EUDAMED. This registration process involves maintaining comprehensive device records and adhering to Unique Device Identifier (UDI) regulations. Our team assists in obtaining UDI codes and integrating EUDAMED registration procedures into your workflow, ensuring compliance when registration becomes a mandatory requirement.
EU MDR and IVDR Post-Market Surveillance (PMS)
The EU MDR and IVDR have introduced enhanced Post-Market Surveillance (PMS) obligations for medical device and IVD manufacturers. Our regulatory experts help businesses establish and maintain robust PMS programs tailored to their specific products. We offer comprehensive support in crafting compliant strategies, preparing detailed PMS reports, and ensuring adherence to EU regulatory expectations for ongoing market compliance.
EC Representative European Authorized Representative for Medical Devices & IVD Companies
Non-EU manufacturers of medical devices and IVDs must appoint a European Authorized Representative (EU AR) to legally sell their products in Europe. An EU AR plays a critical role in managing regulatory documentation, handling incident reporting, and ensuring compliance with post-market requirements. With a network of regulatory professionals across Europe, we provide reliable EU AR services, acting as both a regulatory liaison and a strategic commercial partner.
CE Mark Notified Body Search and Selection
Selecting the right Notified Body is crucial for securing CE Mark certification, but the process can be complex due to limited availability and varying expertise among different Notified Bodies. Delays or missteps in this selection can lead to increased costs and potential market access setbacks. Our experts streamline the Notified Body selection process, guiding you in identifying, assessing, and engaging with the most suitable organization to facilitate a smooth certification and approval journey.
EU MDR & IVDs PRRC Person Responsible for Regulatory Compliance
The EU MDR and IVDR mandate that medical device and IVD manufacturers appoint a Person Responsible for Regulatory Compliance (PRRC). This role oversees adherence to regulatory standards, quality management, and post-market surveillance. The designated PRRC must meet strict qualification criteria, including a relevant degree with one year of regulatory experience or a minimum of four years in regulatory affairs or quality management. We provide expert guidance to help you fulfill PRRC requirements and ensure continuous regulatory compliance.
