中文|English
中文|English
Does Class B medical device CE certification require annual review?
Release time：2024-08-15 15:36:02 The author: source:
Post-Market Surveillance: Continuously monitor the device’s performance and report any adverse events.

Class B medical device CE certification itself does not require an annual review. However, you must adhere to ongoing regulatory obligations, including:

  1. Post-Market Surveillance: Continuously monitor the device’s performance and report any adverse events.

  2. QMS Maintenance: Regularly update and maintain your Quality Management System (QMS) to ensure compliance with ISO 13485.

  3. Notified Body Communication: Inform the Notified Body of significant changes to the device or manufacturing processes.

  4. Certification Renewal: CE certification is typically valid for 5 years. You need to apply for recertification before the certificate expires to continue marketing the device in the EU.

Although there is no formal annual review, staying compliant with these ongoing requirements is crucial for maintaining certification.

louis-reed-JeInkKlI2Po-unsplash(3).jpg

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


Last one: How long does it take to obtain Class B medical device CE certification?
The next one: How long does it take to obtain Class B medical device CE certification?
return