Medical Device Europe Compliance
To access the European market, manufacturers must demonstrate full conformity with MDR 2017/745 and obtain CE Marking. Sobel provides tailored support for medical device Europe compliance, helping you prepare documentation, conduct evaluations, and work effectively with Notified Bodies.
Who benefits from our medical device Europe compliance services
Medical Device Manufacturers
requiring expert guidance to align with MDR 2017/745 and achieve CE Marking certification.
International Companies
looking to expand into Europe with support in regulatory submissions, documentation, and Authorized Representative services.
Startups and Innovators
seeking strategic consulting to reduce time-to-market and avoid regulatory pitfalls.
Regulatory Affairs Teams
needing assistance with technical files, clinical evaluation reports (CER), and ongoing MDR updates.
End-to-end support
Bringing a medical device into the European market requires compliance with MDR 2017/745 and CE Marking procedures. Many manufacturers face recurring doubts when preparing documentation, working with Notified Bodies, and managing post-market responsibilities.
Here are some of the most common questions:
What is MDR 2017/745 and why is it important?
The Medical Device Regulation (MDR 2017/745) is the legal framework that governs all medical devices in Europe. It defines classification rules, conformity assessments, and post-market obligations. Compliance with MDR is mandatory for any device placed on the European market.
What is required to obtain CE Marking for medical devices?
CE Marking shows that a device meets European safety and performance standards. To obtain it, manufacturers must prepare technical documentation, conduct risk and clinical evaluations, and complete the appropriate conformity assessment. Sobel supports companies throughout this process, ensuring alignment with EU expectations.
Do manufacturers need an EU Authorized Representative?
Yes — companies without a physical presence in the EU must appoint an Authorized Representative. This entity is legally responsible for communication with regulators and for holding documentation such as the technical file. Sobel provides Authorized Representative services for non-EU manufacturers.
What are post-market surveillance obligations under the MDR?
Manufacturers must continuously monitor the safety and performance of their devices once on the market. This includes vigilance reporting, periodic safety updates, and corrective actions if necessary.
Sobel helps you manage every step of MDR compliance, giving your company clarity, efficiency, and confidence to grow in Europe.
How Sobel supports medical device Europe compliance
Meeting the requirements of MDR 2017/745 and achieving CE Marking demand precise documentation, structured evaluations, and constant alignment with regulatory updates. Without the right expertise, these steps can slow down market entry.
Sobel provides practical and strategic support at every stage. Our consultants assist in compiling and reviewing technical files, preparing Clinical Evaluation Reports (CER), coordinating biological and toxicological assessments, and implementing risk management in line with ISO 14971.
For non-EU companies, Sobel acts as your Authorized Representative and offers PRRC (Person Responsible for Regulatory Compliance) services, so your obligations are covered by a trusted local partner.
By working with Sobel, your company gains agility, regulatory confidence, and stronger positioning to compete successfully in the European medical device market.
Regulatory compliance for medical devices with Sobel
You can count on Sobel to provide comprehensive support for medical device Europe compliance, covering the full pathway to CE Marking and MDR 2017/745 obligations.
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CE Mark Regulatory Support
Gap analysis, technical documentation, and ongoing regulatory for CE Mark for Medical Devices.
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Biological Evaluation (BEP, BER)
Expert biological evaluation services. BEP, BER, Gap analysis, and regulatory support.
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Clinical Evaluation (CEP & CER)
Structured clinical evaluation. CEP, CER, literature search, and Notified Body support.
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Toxicological Risk Assessment (TRA)
TRA aligned with EU MDR and ISO 10993 series, supporting chemical safety evidence.
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European Authorized Representative
EAR for medical devices, supporting regulatory oversight and access to the EU market.
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Quality Management Services
Quality management support, aligned with EU MDR and ISO 13485 requirements.
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Internal Audits
Internal audits supporting ISO 13485 compliance and notified body readiness in Europe.
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Supplier Qualification and Audit
Audits and qualification aligned with ISO 13485 and EU MDR for medical devices.
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From compliance to confidence
Expanding into Europe’s medical device market requires more than technical expertise — it demands a reliable regulatory partner. Sobel simplifies the MDR process, helping your company turn compliance into a competitive advantage.
By partnering with us, you gain:
Expert guidance on MDR 2017/745 and CE Marking procedures.
Reduced risk of delays, rejections, or costly rework.
Support with technical documentation, CER, and post-market requirements.
Local presence through Authorized Representative and PRRC services.
EU MDR compliance made simple
From documentation to Authorized Representation, Sobel supports every step of your medical device journey in Europe.
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