Regulatory Open Forum

Hello,

As we proceed with registering our company's medical devices (Class I and IIa, IIb) for EUDAMED, I have some questions regarding specific devices. 

1- Medical device "X" was class IIb and discontinued in 2013. This device does not have any UDI-DI/GTIN number because it was discontinued before UDI requirements (the device has Basic UDI-DI). The service life for this device was 7 years and that does not stop people from using them beyond service life 7 years (it means there is a possibility of adverse event!). My questions are as follows. Please advise!

1. if this device considered as legacy device? 
2. if we need to register this product in EUDAMED database, under MDD?
3. if we need to create a new EUDAMED DI for this product? how? 

2- Another situation is about the new device (Class IIb) which only has 510k clearance letter and has not received an EC cert yet. For registering this device in EUDAMED, should we wait until the device complies with the MDR, or is another approach needed? Please advise!

Thank you,

Azadeh

1. a. This is not a legacy device because that would imply it is still being placed on the market. It is an 'old' device. 

1. b. Registering a required if you want to place a device on the market, either via the notified body or via EUDAMED. Until EUDAMED becomes mandatory, you can maintain your notified body registration. However, at some stage, EUDAMED may be required for incident reporting. At that stage you may still need a registration in EUDAMED. 

1. c. If you register a legacy device of an old device in EUDAMED, the system will automatically create a EUDAMED-DI and EUDAMED-ID which you can use for EUDAMED communication instead of UDI.
2. You can only register a device in EUDAMED if it is certified under the MDR (including self-certified devices). So you have to wait with that until there is a CE certificate. Probably needless to mention you have to tak a big step from FDA clearance to CE certification. 

Hello,

As we proceed with registering our company's medical devices (Class I and IIa, IIb) for EUDAMED, I have some questions regarding specific devices. 

1- Medical device "X" was class IIb and discontinued in 2013. This device does not have any UDI-DI/GTIN number because it was discontinued before UDI requirements (the device has Basic UDI-DI). The service life for this device was 7 years and that does not stop people from using them beyond service life 7 years (it means there is a possibility of adverse event!). My questions are as follows. Please advise!

1. if this device considered as legacy device? 
2. if we need to register this product in EUDAMED database, under MDD?
3. if we need to create a new EUDAMED DI for this product? how? 

2- Another situation is about the new device (Class IIb) which only has 510k clearance letter and has not received an EC cert yet. For registering this device in EUDAMED, should we wait until the device complies with the MDR, or is another approach needed? Please advise!

Thank you,

Azadeh