The medical devices that has same intended use, same technological characteristics, biological aspects are considered as the equivalent device. As per MDR, the equivalent device selecting to be CE marked. To claim equivalency, it is mandatory to demonstrate the clinical, technical and biological characteristics are same.
The scientific literature selected for the collection and analysis of the clinical data to be the clinical studies done on the equivalent device for the demonstration of the safety and performance of the medical device for the CE marking. According to MDR, it is mandate to hold an agreement with the manufacturer company of the equivalent device to present the evidences for the demonstration of equivalence.
If the devices that do not have CE marking can be used for the equivalency? What is the difference of equivalent device with the similar device?
The device with which we are claiming equivalency should generally be a CE marked device. However exceptions are possible in few cases, depending on few things such as: the regulatory status of that device, whether data of that device sold in other markets is transferable to the European population and whether we are able to analyze and fill the gaps related to the safety and performance of the device.
According to MDR, a device is considered as an equivalent device when it is technically, biologically and clinically equivalent to device under evaluation. Two devices are considered as similar devices when they belong to the same generic device group. The definition given by MDR for generic device group is ‘a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics’. So, the devices which belong to the same generic device group with similar intended purpose can be considered as similar devices. But their specific technical, biological and clinical characteristics should also match for them to be considered as equivalent devices.
In addition to above comment, I would like to add –
YES, non-CE devices can also be used for equivalency purpose, BUT with proper Justification for use of its data in CER, which explains
• if clinical data of the same is transferrable to European population
• the safety and performance gap analysis related to clinical performance, good clinical practices (such as ISO 14155) and relevant harmonized standards
Difference between Equivalent and similar device is as follow:
EQUIVALENT DEVICE
• Equivalence generally should be based on the single device, otherwise justification needs to be provided
• All three characteristics (clinical, technical, biological) needs to be fulfilled for a device to be equivalent
• Contract between both the manufacturers is must for high risk devices (implantable devices and class III devices) to access its technical documentation on ongoing basis
• Equivalent device must be CE marked, otherwise proper justification needs to be provided
• Manufacturer of equivalent device allows sufficient levels of access to the its technical documentation for conformity assessment
SIMILAR DEVICE
• Similarity can be based on many devices with similar clinical characteristics
• Most of the characteristics (clinical, technical, biological) need to be fulfilled with at least same/similar INTENDED USE for device to be similar
• NO need of contract between the manufacturers of similar or subject device
• Similar device need NOT necessarily to be CE marked
• Similar device data can be accessed from published data like pubmed etc
In addition to the above comments,
Equivalent device is used for establishing the general the safety and performance through the clinical, technical and biological parameters. The clinical evidence from the equivalent device is used for clinical evaluation. Whereas, literature of similar device can be used for purposes like: Understanding the state of the art, alternative available treatment options and design of study and the natural course of disease, to define the scope of clinical evaluation, identifying safety and performance features in similar devices, to identify the clinical benefit based on the published clinical data pertaining to the similar devices.