European Market

Welcome to the European Medical Device Market

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.

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

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 Support

Our service ensures compliance with MDR 2017/745, particularly Article 10 and Annex I, Chapter I, by helping you establish, implement, document, and maintain a risk management system. We support adherence to ISO 14971 standards, ensuring all risks are minimized and managed effectively for patient and user safety

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.


Toxicological Risk Assessment

Toxicological risk assessments ensure medical devices comply with EU MDR 2017/745, particularly addressing chemical, physical, and biological risks under Annex I GSPR. They include justifications for CMR substances per GSPR 10.4.3, incorporate risk mitigation strategies, and provide detailed reports to meet regulatory requirements, ensuring device safety and effectiveness before market entry

Clinical Evaluation

We offer clinical evaluation services for medical devices, ensuring compliance with MDR 2017/745 in Europe. Our services include the preparation of Clinical Evaluation Reports (CER) as required by Annex XIV. We also assist in drafting the Summary of Safety and Clinical Performance (SSCP) for class III devices, ensuring your device meets regulatory requirements and performs safely.

Person responsible for regulatory compliance (PRRC)

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.

European Authorized Representative

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.

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.


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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