To enter the European market, medical devices must comply with CE Mark requirements.
Sobel supports manufacturers and importers with structured regulatory services to help define the pathway, address compliance gaps, and move forward with confidence.
From early planning to ongoing compliance, our experts help transform CE Mark Medical Devices regulatory requirements into a manageable, business-oriented pathway.
CE Mark compliance is a legal requirement for medical devices in Europe; without it, market access is impossible.
CE Mark is required for all medical device classes in Europe, ensuring compliance across the entire product range, from low to high risk.
With expert guidance, you minimize risks of non-compliance and reduce the need for rework or redesign.
With MDR 2017 fully in force, CE Mark Medical Devices are subject to stricter documentation, traceability, and lifecycle requirements.
MDR 2017 establishes different regulatory expectations depending on risk class, device type, and lifecycle stage. For CE Mark Medical Devices, Sobel offers the following regulatory support options:
Recommended for manufacturers preparing for MDR alignment or reviewing their current regulatory readiness. This service assesses whether your existing documentation, evaluations, and post-market information are aligned with applicable CE Mark requirements, helping identify regulatory gaps and priorities before moving forward.
Designed for higher-risk medical devices subject to increased regulatory scrutiny. This gap analysis focuses on the alignment of technical documentation, clinical and biological evaluations, risk management, and post-market considerations with MDR 2017/745 and applicable guidance, supporting informed regulatory decisions for complex devices.
Intended for manufacturers that need to compile CE Mark–compliant documentation for lower-risk devices. Sobel structures the technical documentation in line with MDR 2017/745 requirements, using the information and evidence provided by your team to build a coherent and submission-ready file.
Suitable for specific Class I device categories that require additional regulatory controls. This service supports the structured compilation of technical documentation under MDR 2017/745, ensuring consistency and traceability across the materials provided.
Developed for manufacturers of higher-risk medical devices requiring robust, MDR-aligned technical documentation. Sobel supports the compilation and structuring of documentation according to Annex II requirements, helping ensure regulatory consistency across complex device portfolios.
Ideal for companies that need ongoing regulatory guidance rather than a one-time service. This support model helps clarify regulatory pathways, confirm device classification, review documentation, and manage regulatory activities over time, adapting to evolving CE Mark requirements.
Best suited for targeted regulatory questions related to CE Mark and EU compliance. This service provides written expert guidance through a structured project platform, helping teams resolve regulatory doubts without committing to a broader project scope.
You may rely on one or multiple services, depending on your device classification, maturity level, and regulatory strategy.
Sobel also supports CE Mark Medical Devices manufacturers with complementary regulatory services, including:
Our team handles regulatory communication, technical documentation, and compliance.
Experience in robust biological evaluation for medical devices, in line with the ISO 10993-1.
Clinical evaluation services. Compliance with MDR 2017/745 in the preparation of the CER.
Managing CE Mark Medical Devices compliance under MDR 2017 requires clarity, structure, and expert guidance. Partner with Sobel Consultancy to strengthen your CE Mark Medical Devices regulatory pathway and build sustainable European market access.
1. Is CE Mark mandatory for all medical devices in Europe?
Yes. CE Mark for Medical Devices is mandatory for all medical device classes intended to be placed on the European market, from low-risk to high-risk devices. The conformity route and regulatory requirements vary depending on the device classification, but CE Marking is always required.
2. Which regulation governs CE Marking for medical devices?
CE Marking for medical devices is governed by Regulation (EU) 2017/745 (MDR 2017/745). This regulation defines classification rules, conformity assessment routes, technical documentation requirements, and post-market obligations.
3. Who is responsible for obtaining the CE Mark?
The manufacturer is primarily responsible for ensuring CE Mark compliance. However, importers and authorized representatives also have regulatory obligations under MDR 2017/745 and must ensure that the device complies with CE Mark requirements before it is placed on the market.
4. What is a CE Mark gap analysis?
A CE Mark gap analysis assesses whether existing documentation and evaluations align with MDR 2017/745 requirements. It helps identify missing elements, inconsistencies, and regulatory risks before proceeding with technical documentation updates or conformity assessment.
5. Can CE Mark documentation be updated using existing data?
Yes. In many cases, CE Mark documentation can be compiled or updated based on existing data and evidence, provided it meets MDR 2017/745 requirements. A gap analysis is often the first step to determine whether existing materials are sufficient or require remediation.
6. How long does it take to obtain CE Mark for medical devices?
Timelines vary depending on device class, documentation readiness, and whether a Notified Body is involved. Lower-risk devices may follow shorter pathways, while higher-risk devices typically require longer timelines due to clinical evidence review and conformity assessment.
Subscribe to our newsletter to receive the latest updates and insights.
You may unsubscribe at any time using the link in our newsletter.