Europe Market

Welcome to Europe

The European market for medical devices undeniably holds immense potential for growth and innovation. However, with the recent implementation of the Medical Device Regulation (MDR) 2017/745, it's important to note that the regulatory landscape has undergone a significant transformation. Consequently, the MDR not only replaces the previous medical device directives 93/42/EEC but also introduces a slew of changes. These changes, in turn, significantly impact medical device manufacturers.

In light of the recent developments, these changes notably include the inclusion of healthcare institution-produced devices, custom-made devices, single-use devices, devices without a medical purpose, and clinical investigations. Consequently, adapting to these new requirements may indeed require additional resources and the initiation of new processes and systems. Further, the MDR aims to reduce technical barriers to trade and significantly enhance post-market surveillance. As such, as companies begin their preparations for the MDR's implementation, staying ahead of the curve will undeniably be crucial for achieving success in this dynamic and promising market.

Registration Process

Sobel | Your partner on every step

Identify Conformity Route




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

Our Services

Regulatory Affairs Support

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.

Quality Management Support

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.

Risk Management

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.


Biological Evaluation

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.


Clinical Evaluation

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.

Technical File Elaboration

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.


European Authorized Representative

Secure your place in the European Union market with Sobel Consultancy’s European Authorized Representative. Specializing in medical device regulatory affairs, we deliver timely CE marking for medical devices, strengthening your global footprint.


Unleash your potential in the complex realm of medical devices through our comprehensive training programs. Our curriculum is designed to cater to your specific requirements, ranging from acquiring a deep understanding of MDR 2017/745 fundamentals to conducting meticulous toxicological evaluations. Rest assured, our training programs are tailored to meet the highest professional standards in the industry.

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