CE Marking of Medical Devices

Medical Devices – Regulation (EU) 2017/745

Which devices are affected?

Regulation (EU) 2017/745 applies to medical devices other than in vitro diagnostic medical devices. In particular, it covers invasive and non-invasive devices, implants, surgical instruments, certain medical software, active devices, custom-made devices, and certain non-medical products listed in Annex XVI.

Analyzing the product’s regulatory status is therefore an essential first step. This analysis is based primarily on the intended use claimed by the manufacturer, the product’s primary mechanism of action, the expected benefits, the intended users, and the information provided with the device.

What are the classes of medical devices?

Medical devices are classified in accordance with the classification rules set forth in Annex VIII of Regulation (EU) 2017/745. The classification is based on a risk-based approach and takes into account, in particular, the duration of use, the invasiveness, the mode of action, the anatomy involved, whether the device is active or implantable, and the potential consequences for the patient or user.

The classes of medical devices are as follows:

• Class I: Low-Risk Devices
• Class IIa: Moderate-Risk Devices
• Class IIb: High-risk devices
• Class III: Devices with the highest risk

The device class determines the applicable conformity assessment procedure, the scope of the notified body’s involvement, and the expected content of the technical documentation.

For certain Class I devices, the manufacturer may draw up the EU Declaration of Conformity under its sole responsibility, provided that the applicable requirements are met. However, the involvement of a notified body is required for Class I sterile devices, Class I devices with a measuring function, Class I reusable surgical instruments, as well as for Classes IIa, IIb, and III.

How do you obtain the CE marking for a medical device?

Obtaining the CE marking for a medical device requires following a step-by-step process.

1. Classify the product: Confirm that the product meets the definition of a medical device as defined in Regulation (EU) 2017/745. This analysis must be consistent with the intended use, claims, instructions for use, and primary mode of action of the product.
2. Determine the risk class: The classification must be performed in accordance with the rules set forth in Annex VIII of the MDR. It must be justified and documented in the technical file.
3. Identify the applicable requirements: Identify the general safety and performance requirements applicable to the device. Determine the harmonized standards, common specifications, MDCG guidelines, or other relevant reference documents to demonstrate compliance.
4. Implement or adapt the quality system: adapt the QMS to the activities and class of the device. It must cover, in particular, design and development, risk management, supplier control, production, traceability, document management, complaints, vigilance, corrective actions, and post-market surveillance.
5. Compile the technical documentation: This must demonstrate the device’s compliance with applicable requirements. It includes, in particular, a description of the device, specifications, design, manufacturing, risk management, verification and validation, clinical evaluation, labeling, information provided by the manufacturer, and post-market surveillance data.
6. Conducting the clinical evaluation: demonstrates that the device’s clinical performance and clinical benefit have been established with respect to its intended use. It must be proportionate to the device’s class, its characteristics, the available data, and the associated risks.
7. Involving a Notified Body: When required by the device’s class, a Notified Body evaluates the quality system and/or technical documentation in accordance with the applicable conformity assessment procedure.
8. Issue the EU Declaration of Conformity and affix the CE marking: After demonstrating compliance, the manufacturer issues the EU Declaration of Conformity and affixes the CE marking to the device.
9. Report the first placing on the market: After obtaining the CE marking and before placing the device on the market, the manufacturer must complete the applicable registrations in EUDAMED.

Medical Devices – Regulation (EU) 2017/746

Which devices are affected?

Regulation (EU) 2017/746 applies to in vitro diagnostic medical devices (IVDMDs). It covers devices intended for the examination of samples derived from the human body, in particular to provide information on a physiological or pathological condition, a medical predisposition, safety and compatibility with potential recipients, or response to treatment.

This category includes, in particular, reagents, calibrators, control materials, kits, instruments, devices, equipment, software, and systems intended for use in in vitro diagnostics, subject to their intended use.

What are the classes at DMDIV?

DMDIVs are classified in accordance with the rules set forth in Annex VIII of Regulation (EU) 2017/746. The classification is based on the risks to the patient, the user, the donor, or public health.

The DMDIV classes are as follows:

• Class A: Low-Risk Devices
• Class B: Moderate-Risk Devices
• Class C: Devices that pose a high risk to the patient or have a significant impact on patient care
• Class D: Devices that pose a high risk to public health

The involvement of a notified body is required for Class B, C, and D devices. It is also required for Class A sterile devices. For other Class A devices, the manufacturer may draw up the EU Declaration of Conformity on its own responsibility, without the involvement of a notified body.

How do you obtain CE marking for a DMDIV?

The CE marking process for a DMDIV follows a similar approach to that for medical devices, but with specific requirements regarding performance demonstration.

1. Classify the product as a DMDIV: confirm that the product meets the definition of a DMDIV under Regulation (EU) 2017/746. This analysis must take into account the intended use, the type of sample, the information provided by the test, the intended user, and the associated claims.
2. Determining the DMDIV class: Classification must be performed in accordance with the rules set forth in Annex VIII of the IVDR. It must be justified and documented in the technical dossier.
3. Identify applicable requirements: Identify the applicable general safety and performance requirements, as well as harmonized standards, common specifications, MDCG guidelines, and other relevant reference documents.
4. Implement or adapt the quality system: adapt the QMS to the activities and class of the device. It must cover, in particular, design and development, risk management, supplier control, production, traceability, document management, complaints, vigilance, corrective actions, and post-market surveillance.
5. Compile the technical documentation (or technical dossier): This must demonstrate that the DMDIV meets the applicable requirements. It includes, in particular, a description of the device, analytical characteristics, performance data, risk management, manufacturing processes, controls, labeling, information provided with the device, and post-market surveillance.
6. Conducting the Performance Evaluation: For DMDIVs, demonstrating compliance is based on a performance evaluation. This evaluation consists of three components: scientific validity, analytical performance, and clinical performance.
7. Involving a Notified Body: Depending on the DMDIV class, the involvement of a Notified Body may be required to assess the quality system, technical documentation, and performance data.
8. Issue the EU Declaration of Conformity and affix the CE marking: Once conformity has been demonstrated, the manufacturer issues the EU Declaration of Conformity and affixes the CE marking to the DMDIV.
9. Report the first placing on the market: After obtaining the CE marking and before placing the DMDIV on the market, the manufacturer must complete the applicable registrations in EUDAMED.

Why seek guidance?

CE compliance requires not only a thorough understanding of regulatory requirements, but also the ability to apply them in a practical manner to the organization, the system, and its lifecycle.

External support makes it possible to:

• Ensure the qualification and classification of the device;
• Develop an appropriate regulatory strategy;
• Identify discrepancies before submission or an audit;
• Organize a coherent technical dossier;
• Anticipate the expectations of the notified body;
• Strengthen compliance with the quality system;
• Prepare for ongoing compliance after the product is brought to market.