Is ISO 13485 certification still valid if the medical device is discontinued?

Question

What happens to an existing ISO 13485 certification if the medical device it was issued in combination with is discontinued? Is the ISO 13485 certification still valid for the company? Would the company need to change their notified body if they no longer produce any medical devices?

Dr. Oliver Eidel · Accepted Answer

ISO 13485 certification is company-specific and not tied to a specific device. You can keep your ISO 13485 certification even if you don't have an active medical device. However, the scope of certification is important. If your company stops producing medical devices altogether, you'll eventually need to discuss the scope of your certificate with your notified body. If there's nothing left to audit (no complaints, no management reviews, no internal audits on products), maintaining the certification can become challenging. But as long as your quality management system is in place and the scope is accurate, the certificate itself remains valid.

Answer

The certificate is independent of CE-marking. If your company moves away from medical devices completely, you may have to update the scope of your certificate. The notified body might review your situation, but you don't need to switch notified bodies just because you're not making devices anymore.

Answer

The scope of your ISO 13485 certificate is key. It's tailored to the devices or services you provide. If you have no devices in production, it's possible to keep the certificate, but demonstrating compliance could be hard over time. For example, you might lack complaints or topics for management review, or relevant areas to audit. If you're still developing new medical devices, make sure your scope is up to date.

Is ISO 13485 certification still valid if the medical device is discontinued?

3 Answers

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