Hi Everyone,
With regards to labelling an electrical medical device in the EU:
Obviously, the CE mark is required.
But what about the following:
- WEEE mark
- RoHS mark
- GS mark (for Germany?)
- Mark to show EN60601-1 compliance (such as the TUV T-mark)
Are the above marks:
- Required to be present on the device labels to market the medical device in Europe?
OR
- Recommended to access markets. Are there markets that are likely to specifically look for such marks (like an NRTL mark in US)?
OR
- Totally optional. Just a way to show compliance to standards or directives?
With regards to labelling an electrical medical device in the EU:
Obviously, the CE mark is required.
But what about the following:
- WEEE mark
- RoHS mark
- GS mark (for Germany?)
- Mark to show EN60601-1 compliance (such as the TUV T-mark)
Are the above marks:
- Required to be present on the device labels to market the medical device in Europe?
OR
- Recommended to access markets. Are there markets that are likely to specifically look for such marks (like an NRTL mark in US)?
OR
- Totally optional. Just a way to show compliance to standards or directives?
).