CE mark
of medical devices and IVDs
Certification for placing on the market
of medical devices and IVDs in the European Union
CE mark
To place a medical device or an in vitro diagnostic device on the European Union market, manufacturers must comply with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). The CE mark for medical devices confirms that a product has followed the applicable conformity assessment route and meets the relevant European requirements for safety, performance and regulatory compliance.
ALTRION provides end-to-end support for CE marking, helping manufacturers manage the regulatory process from the initial classification of the device to Technical Documentation preparation, Notified Body coordination and Post-Market Surveillance management.
Obtaining CE marking for medical devices is not only a formal requirement. It is a structured regulatory pathway that involves product qualification, classification, risk management, clinical or performance evaluation, quality system alignment, technical evidence and continuous post-market obligations. ALTRION supports companies through each phase with a practical and technically grounded approach, helping them prepare the documentation and processes required to access and remain on the EU market.
CE marking support for medical devices and IVDs
Medical device CE marking requires a clear understanding of the applicable regulatory framework, the intended purpose of the device and the correct conformity assessment procedure. ALTRION assists manufacturers of medical devices and IVDs in defining the appropriate regulatory strategy under MDR or IVDR, helping them identify the documentation, evidence and procedural steps needed to demonstrate conformity.
Our support is designed for companies that need reliable medical device regulatory consulting, whether they are preparing a new CE marking project, updating existing documentation, managing a transition to MDR or IVDR, or coordinating with a Notified Body for conformity assessment.
Device Classification
The classification of a medical device is one of the first and most important steps in the CE marking process. ALTRION supports manufacturers in determining the correct device classification, including Class I, Is, Im, IIa, IIb and III, based on the intended purpose, mode of action, duration of use, invasiveness and applicable classification rules.
A correct classification is essential because it determines the conformity assessment route, the level of Notified Body involvement and the type of documentation required. Misclassification can lead to delays, additional requests, regulatory gaps and unnecessary costs. ALTRION helps manufacturers approach this phase with accuracy, reducing uncertainty from the beginning of the CE marking pathway.
Technical Documentation and Clinical Evaluation
Technical Documentation is the backbone of CE marking for medical devices. ALTRION supports the preparation and structuring of Technical Documentation according to Annex II and Annex III of the MDR, helping manufacturers organize the evidence required to demonstrate compliance with applicable safety and performance requirements.
This activity may include the preparation of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in compliance with MDCG guidance. Clinical evaluation is a key part of the CE mark for medical devices, as it connects clinical evidence, intended use, risk-benefit profile and performance claims. ALTRION helps manufacturers develop documentation that is structured, coherent and aligned with regulatory expectations.
Risk Management, Usability and Software Documentation
Risk management is a central requirement for medical device regulatory compliance. ALTRION supports the preparation of the Risk Management File in accordance with ISO 14971:2019, helping manufacturers identify hazards, estimate and evaluate risks, define control measures and document residual risk acceptability.
For devices where usability and software are relevant, ALTRION also supports Usability Engineering documentation according to IEC 62366-1 and Software Life-Cycle documentation according to IEC 62304. These activities are particularly important for devices involving user interaction, embedded software, stand-alone software or digital medical technologies. By integrating risk management, usability and software documentation, manufacturers can build a stronger and more consistent technical file for CE marking.
Notified Body Coordination
Depending on the classification and type of device, manufacturers may need to involve a Notified Body for the conformity assessment procedure. ALTRION supports coordination with Notified Bodies for procedures under Annex IX, Annex X and Annex XI, helping manufacturers prepare, submit and manage the documentation required during the assessment.
Notified Body interactions can be complex and time-sensitive. Clear documentation, organized evidence and precise responses to requests are essential to avoid unnecessary delays. ALTRION assists manufacturers throughout this process, supporting communication, documentation review and follow-up activities connected to the CE marking assessment.
Declaration of Conformity and EU Representative Designation
Once the applicable conformity assessment process has been completed, the manufacturer must prepare the EU Declaration of Conformity. This document formally states that the medical device complies with the relevant requirements under MDR or IVDR and allows the manufacturer to affix the CE mark where applicable.
ALTRION supports the preparation of the Declaration of Conformity and, where required, the designation of an EU Representative (EU-REP). For non-EU manufacturers, the EU Representative plays an important role in placing medical devices on the European market and maintaining compliance with regulatory obligations. ALTRION helps companies manage this step as part of a broader CE marking and market access strategy.
Post-Market Surveillance, PSUR, PMCF and Vigilance
CE marking does not end when the device enters the market. Manufacturers must continue to monitor the safety and performance of their medical devices through Post-Market Surveillance activities. ALTRION supports the preparation and management of PMS documentation, including PMS Plans, Periodic Safety Update Reports (PSUR), Post-Market Clinical Follow-up (PMCF) activities and vigilance processes.
These post-market activities are essential to maintain medical device compliance over time. They help manufacturers collect real-world data, identify potential issues, update the technical documentation and meet ongoing regulatory obligations. ALTRION helps companies build post-market processes that are not only compliant, but also useful for long-term product monitoring and continuous improvement.
FAQ about CE mark for medical devices
What is the CE mark for medical devices?
The CE mark for medical devices confirms that a device has followed the applicable conformity assessment route and meets the relevant European requirements for safety, performance and regulatory compliance under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR).
Is CE marking mandatory for medical devices in the European Union?
Yes. To place a medical device or an in vitro diagnostic device on the European Union market, manufacturers must comply with MDR or IVDR requirements and obtain CE marking where applicable. This process demonstrates that the device is suitable for EU market access.
Why is device classification important for CE marking?
Device classification determines the conformity assessment route, the level of Notified Body involvement and the type of documentation required. Correct classification helps reduce regulatory uncertainty, avoid delays and define the right CE marking strategy from the beginning of the process.
What documentation is required for CE marking?
CE marking requires structured Technical Documentation, including evidence related to safety and performance, risk management, clinical evaluation where applicable, labeling, Instructions for Use and post-market documentation. ALTRION supports the preparation of MDR/IVDR-compliant Technical Documentation according to the applicable requirements.
Does CE marking end once the device is placed on the market?
No. CE marking continues after market placement through Post-Market Surveillance activities. Manufacturers must monitor device safety and performance, maintain PMS documentation, manage PSUR or PMCF activities where required and handle vigilance obligations to keep the device compliant throughout its life cycle.
Why Choose ALTRION
With over 20 years of experience in MDR transition and EU conformity assessments, ALTRION supports manufacturers through the complex regulatory steps required to obtain and maintain CE marking for medical devices. Our multilingual team can assist with documentation in English, French and Italian, making the process smoother for companies operating across different European markets. Thanks to in-depth experience with Class I, Is, Im, IIa, IIb and III devices, IVDs and software as a medical device (SaMD), we provide tailored support based on the specific characteristics and regulatory profile of each product. ALTRION also helps ensure seamless coordination between the EU manufacturer, the EU Representative and the Notified Body, reducing delays and improving the overall efficiency of the conformity assessment process.
Deliverables
ALTRION provides the key documentation and regulatory support needed to complete the CE marking process and maintain compliance after market placement.
- MDR/IVDR-compliant CE Technical Documentation.
- EU Declaration of Conformity.
- Support during Notified Body review and audit follow-up.
- PMS and vigilance documentation for post-market compliance.
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