Good morning!
The amount of "creativity" allowed will depend on the risk class of the device.
Keep in mind that Article 61(4) refers to implantable and class III devices. For lower class devices, we have seen the NB allow 3rd party devices to be used for equivalence. (See MDCG 2020-5 for a more in-depth explanation)
If your device is implantable or class III and is a legacy device, published clinical studies conducted by researchers not sponsored by the manufacturer are also acceptable (see MDCG 2020-6, Appendix III for a hierarchy of clinical evidence, ranked by quality). Outside of those, it would be a stretch for the NB to approve a higher risk device with little to no clinical data.
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Bethany Chung
Principal Regulatory Scientist, RQM+
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Original Message:
Sent: 15-Jun-2022 02:12
From: Anonymous Member
Subject: Medical Device Clinical Evaluation - Equivalence
This message was posted by a user wishing to remain anonymous
Hello, community,
Can anyone share his creative solution or idea to the CER-Equivalence issue other than clinical studies?
Assuming that the manufacturer doesn't have a contract in place with the other manufacturer that allows full access to the technical documentation of the device claimed as equivalent.
The NB do not accept solutions such as performing functional or reliability tests made on the equivalent device in comparison to functional test made on our products (with statistical rationale) as sufficient.
Thank You