How Medical Devices Obtain CE Marking

What is CE Marking for Medical Devices?

To sell medical devices in the European Union (EU), products must bear the CE mark. The CE mark indicates that the medical device complies with applicable EU regulations and can be sold in all EU member states. As a legitimate medical device manufacturer, whether or not any part or all of the manufacturing process is outsourced to others, you are responsible for ensuring regulatory compliance and affixing the CE mark to your products. Manufacturers of in vitro diagnostic medical devices (IVDs) must also meet similar requirements to obtain the EU CE mark.

How Medical Devices Obtain CE Marking

The CE mark not only represents recognition of quality but also proves that the product complies with the requirements of EU Medical Device Regulations (MDR 2017/745) and meets the performance, quality, safety, and efficacy standards set for its product type.

The following is the basic process for obtaining EU CE certification for medical devices, which mainly involves the following steps:

1. Determine if the product meets the definition of a medical device according to the MDR.

2. Determine the classification of the device.

3. Implement a quality management system (if applicable to the device). Most companies adopt ISO 13485 to meet requirements.

4. Prepare a CE technical file or design dossier.

5. Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev 4 and MDR requirements.

6. If there is no physical presence in Europe, select and appoint an EU Authorized Representative (EC REP) to act on behalf within the EU.

7. Choose a Notified Body to audit the quality management system and technical file/design dossier unless the device is Class I non-sterile and non-measuring.

8. Obtain the CE mark and ISO 13485 certificate from the Notified Body.

9. Prepare a Declaration of Conformity (DoC) stating that the device complies with MDR.

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