Why is it important to have CE marking for medical devices?
CE marking is an indicator of a medical device’s compliance with EU legislation. CE mark on a medical device is an indication of the manufacturer’s verification that the device complies with all relevant and essential requirements (such as safety and performance requirements of the MDR) or, depending on the device class, it gives proof that the manufacturer has had it examined by a notified conformity assessment body.
CE marking was set up to harmonize the different requirements of products across all European nations, making it simpler and more efficient for companies and organizations to trade across Europe.
By affixing the CE marking on a medical device, a manufacturer is declaring, on its sole responsibility, conformity with all of the legal requirements applicable to that product. Falsely affixed CE marking can lead to civil or criminal liabilities.
Simplified steps for achieving CE marking
Many people who are not familiar with the subject, commonly refer to CE mark as a quality mark when, in reality, it is more of a safety mark, meaning that the medical device has been assessed to be in compliance with all applicable requirements.
Here are few steps for achieving CE marking for medical devices:
- Identify the directive or regulation and harmonized standards applicable to the device.
- Verify the device-specific requirements.
- Identify whether an independent conformity assessment is required from a notified body.
- Establish technical documentation.
- Draw up declaration of conformity.
About the author
Jonas Hinkkanen is Head of Regulatory Affairs in Nordic and Baltic regions at Biocodex. He has more than 15 years of experience in quality management, quality assurance and regulatory affairs. Over the years, Jonas has acted in a leading role in various medical device companies. His proficiency includes EU MDR, FDA QSR, MDSAP, ISO13485, ISO 14971 as well as IEC 62304. He is also a member of the IEC 62B standardization working group.
Want to learn more about CE marking for medical devices? Reserve your spot and register now for the webinar!
CE marking – What do I need to know? 28.5.2020 at 14:00 – 15:00 (GMT+3) / Price 50 € (+ 24%)
- importing products from outside EU
- distributing products manufactured in EU
- need for additional labeling – localization of the product
Speaker: Jonas Hinkkanen, Head of Regulatory Affairs, Biocodex Oy
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