Update to software after CE-certificate has expired.

M

Martin Med

Registered
We have placed on the market an (MDD certified) active device with an integrated software component. To perform according to the device's intended use the software requires minor updates from time to time. Think updates to stay compatible with other operating systems and such.

The MDD certification of this product will expire in August. Following the regulations we will no longer sell this device from that date, although our distributors will have some stock left for sale. However, the minor updates will remain necessary throughout the device's lifetime (1.5 years).

My question: Can we continue to update the software component of this device, even though the CE-certificate has expired?

My gut says no, but would love to know your thought (and any relevant documentation! Couldn't find any myself).
 
C

Cybel

Involved In Discussions
You would inform our NB of these changes? If they are "minor updates" I guess they are not significant changes.
Your device shall be able to work for its lifetime. If periodic SW updates are a requirement for safety/performance and they are not significant changes, I guess it should be updated (otherwise, you can't keep on the market a device which has lost its safety performance due to missing SW updates...)

From Article 120(3) of Regulation 2017/745 (MDR):
3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.
 
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