CU TR 020\2011 – EMC

Custom Union regulation is applicable for active devices except of components (spare parts) – full text (in Russian).There is a list of applicable standards – see here (in Russian).

Custom Union DoC formally applied for EEU countries but it could be used only in countries where medical device is registered (medical device has national registration certificate).

| How long does it take to receive DoC? 

2-3 weeks.

| What is required for CU TR? 

List of documents:

1. Registration certificate (s) for national registration systems in EEU,

2. Test reports for applicable standards,

3. Local company who presents interests of manufacturer on Russian Federation territory (who is in charge of quality).

| What is expiry date of DoC CU TR?

5 years.

| Who can issue DoC CU TR?

Notified body – accredited in EEU for TR 020\2011 with medical devices in scope. Formally Notified Body (ND) doesn’t issue but register declaration of conformity.