Navigating the European market for medical devices requires a deep understanding of the Medical Device Regulation (MDR) 2017/745. This regulation, which came into full force in May 2021, sets a new benchmark for the safety and efficacy of medical devices sold within the European Union.
Central to the MDR are Notified Bodies. These independent organizations are designated by EU countries to assess whether a medical device meets the stringent requirements of the MDR. If you’re a manufacturer, working with a Notified Body is a critical step. They review your device, especially if it’s considered high-risk, to ensure it complies with the regulation. Their approval is your green light to market your device in the EU.
Moreover, the MDR places a strong emphasis on the biological and clinical evaluation of medical devices. This means that before your device can hit the market, you must thoroughly document its safety and the clinical benefits it offers. It’s not just about proving your device works; it’s about demonstrating it’s safe for patients and achieves the intended outcomes 2.
These evaluations form a significant part of your technical documentation, reviewed by Notified Bodies. The goal is clear: to ensure that all medical devices used within the EU are held to the highest safety standards, benefiting patients and healthcare systems alike.
Understanding and complying with the MDR 2017/745, including engaging with Notified Bodies and conducting comprehensive evaluations, is essential. It’s the pathway to successfully launching your medical device in the European market, ensuring it’s safe, effective, and ready to make a difference in patients’ lives.
Identify Conformity Route
Implement
Conformity
Requirements
Appoint EU-REP
for NON-EU Manufacturer
Notified Body Assessment
Audits and technical documentation assessment
Ready to sell
Mark device with CE sign and start commercalization
Navigate the complex world of regulatory affairs with our comprehensive Regulatory Service. From strategic planning to gap analysis and continuous support, we ensure alignment with MDR 2017/745 for a seamless business operation.
Sobel Consultancy’s MDR Quality Management Support offers unparalleled assistance in harmonizing your existing quality management system with the requirements of EU MDR 2017/745. Leveraging years of experience in medical device regulatory affairs, we ensure that your business stands tall amidst regulatory shifts and changes.
Manage medical device risks effectively with ISO 14971-based Risk Management Support. Expert planning, comprehensive risk analysis, and effective control measures are at your disposal. A final report evaluates overall risk, ensuring safety and compliance.
Experience seamless Biological Evaluation for medical devices, meticulously aligned with ISO 10993 standards. Our all-inclusive service offers evaluation planning, material characterization, toxicological assessment and study monitoring if needed. Trust our experts to deliver a comprehensive report affirming device safety. With us, you receive the full package, eliminating any concern.
Experience our Clinical Evaluation Service, meticulously structured to align with MDR 2017/745 standards. Tailored for medical devices, it encompasses planning, exhaustive literature reviews, product verifications, validations, and clinical data analysis. Trust our experts to deliver a comprehensive report confirming your device’s safety and performance.
An embodiment of our deep-rooted expertise in compiling robust medical device documentation. This service aligns with annex II of the MDR 2017/745, guaranteeing a comprehensive, authoritative technical file that resonates with assurance and reliability. Trust our dedicated problem-solving approach for your CE file needs and witness the exceptional difference we bring to your compliance journey.
Ensure MDR 2017/745 compliance with our PRRC service. Essential for market entry, this role oversees the technical documentation, risk management, and post-market surveillance. Avoid fines and enhance product safety with expert regulatory guidance. Perfect for companies needing seamless, professional compliance support to be compliant with the MDR 2017/745.
Ensure MDR 2017/745 compliance with our European Representative service. Essential for non-EU manufacturers, this role handles regulatory communication, maintains technical documentation, and assists with vigilance reporting. Avoid market entry barriers and ensure seamless EU market access with expert support. Perfect for navigating complex regulatory landscapes.
