Your Medical Device Needs CE Marking to Export to Europe

The European medical technology market was estimated to be worth €140 billion in 2020. This is a promising market for non-EU medical device manufacturers. First, they need a CE Mark according to the risk classification to export to countries in the EU.

What Is CE Marking for Medical Devices?

CE stands for Conformité Européenne. The CE Mark appears on products traded on the extended Single Marker in the European Economic Area. The mark signifies that the product meets the safety, health, and environmental protection requirements set by the European Commission.

The CE marking indicates that the product has met the General Safety and Performance Requirements set by Medical Device Regulations (MDR). Medical devices are classified into classes, similar to that of the Food and Drug Administration in the U.S. The whole goal of the changes of the economic operator in the MDR/IVDR is to have a separate entity in the supply chain for additional traceability. Competent authorities can act if they do not see this in the IVDR importer registration.

How Are Medical Devices Classified?

All medical devices undergo stringent technical documentation for CE marking. Factors that affect classification are the characteristics of the devices. Are they non-invasive? Most devices that do not penetrate the body are typically considered Class I. However, some exemptions would result in the product’s higher classification.

Invasive (enter the body through the skin or any orifice) and active (require an energy source) devices are classified higher. Duration of use and reusability also affect classification.

Steps to Obtain CE Marking for Your Medical Device

1. Classify Your Medical Device

The most crucial step is to correctly classify your medical device. The MDR’s decision tree indicates specific rules that will help determine your device’s associated risks and classify it accordingly.

2. Create Quality Management System

A Quality Management System (QMS) includes all policies and procedures related to every step in the design, manufacture, and distribution process of your medical device. This is a mandatory requirement for any company that wishes to enter the medical device market.

3. Create Technical File

Your medical device’s technical file covers all device details to ensure that it meets all MDR importer requirements. These include:

• a) Name and address of the company, facilities involved in design and manufacture, and the NB

• b) Product description and serial number

• c) EU declaration of conformity

• d) Instructions for use, parts list, and test results

• e) Compliance with technical standards and regulations

4. Obtain Certification

Unless the device is under self-certifying class I, you must apply for certification of conformity to essential requirements from an NB.

You can partner with CE marking companies for support throughout these steps.

5. Affix the CE Mark

When all requirements are satisfied, you can create a Declaration of Conformity, and the CE mark will be placed on your medical device.

Emre Aykaç MSc. is the managing director of GrowthImports. He developed the growth of various medical device manufacturers in 25+ countries and led international sales teams.