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The CE Mark For Medical Devices: Self-Certification Versus Higher Device Classes*

The CE Mark and approval under the European Commission’s Medical Devices Regulation is the key to opening the European market for medical devices. While Notified Bodies are the key for higher level medical devices, Class 1 devices can receive the CE Mark via creation of a registration dossier that complies with the EN standards that govern the CE Mark for medical devices by Israeli, US, and other non-European companies as well.Requirements include:

1. Safety Testing Data.

To self-register under the CE Mark, safety data is required. This should be generated based on EU standards governing safety for medical devices.

2. Efficacy Testing Data.

2.If claims of efficacy are made for the medical device, the CE Mark standards also specify what kinds of testing are required.

3. Adverse Event Reporting. 

3.For any device on the market, adverse event reporting for users of that device – problems that users experience – need to be collected by the company and reported if necessary. This should be done according to the EU’s quality systems for medical devices standards, EN 13485 and related medical device standards to ensure compliance.

4. Authorised Representative.

For companies such as those in Israel and the United States, a European-Union-based “authorized representative” has to be appointed to be the official address for issues regarding that medical device in the CE Mark European market. Authorised representatives vary from a mere address with virtually no service levels to highly sophisticated medical device-savvy companies. The yearly cost of an authorized representative is generally proportionate to the level of service the company can provide.

5. Higher Level Device Approvals under the CE Mark.

5.For medical devices above Class 1, the portal to the medical device approval process is via the semi-official “Notified Bodies” based in each European Member State. Companies should think carefully about device classification issues before resorting to a higher level classification, which entails gteater approval requirements and costs.

* Information contained on this page is not meant to constitute or substitute for specific legal advice addressing actual legal situations as is meant as general guidelines only. Readers are advised to seek competent legal counsel appropriate and tailored to their particular legal situation.