#1
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?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
We are talking two different things here.

CE marking is a mandatory regulatory requirement. When you give it to yourself (yes, you give it to yourself, not anyone else give it to you), it means you comply with the applicable european directives relevant to your product.

MDD, AIMMD, IVDMM, RoHS and WEEE are European directives.

If your device is a medical electrical device, you may need to be compliant with: MDD, RoHS (depending on the date), WEEE, maybe the EMC directive, maybe the Machine Directive, maybe the General Product Safety Directive.

Again, this is mandatory.


Although CE Marking it is called marking in general, it has nothing to do with certification marks, which are voluntary.

GS mark (Gepr?fte Sicherheit ("Tested Safety")) or mark to show EN60601-1 compliance (such as the TUV T-mark) are voluntary certification marks. Generally they are not required (one clear case in which such usual voluntary marks are required are the UL components required by the US), but can be used to help fulfill requirements of regulations.

So they are totally optional. Just a way to show compliance to directives. Note that for the directives, even the standards are voluntary too.
 
Last edited:
#3
Thanks Marcelo.

For most medical electrical equipment, yes, RoHS and WEEE, and of course either MDD, AIMMD or IVDMM will apply.

From the directives, it appears:

  • For the RoHS2 (2011/65/EU), there is no particular marking requirement.
  • For the WEEE (2012-19-EU), a marking with the WEEE is required. If not on the device itself (due to space or function), at least on accompanying packaging, IFU and warranty (see Article 14(4))

GS mark (Gepr?fte Sicherheit ("Tested Safety")) or mark to show EN60601-1 compliance (such as the TUV T-mark) are voluntary certification marks. Generally they are not required (one clear case in which such usual voluntary marks are required are the UL components required by the US), but can be used to help fulfill requirements of regulations.
Yes, EN60601-1 compliance goes a long way to fulfill requirements of regulations (side-note: hats-off to any manufacturer that does not go this route! :yes:).
...but my question is specifically regarding marks. If claiming compliance, is such marks on the product required, or is it sufficient just to maintain appropriate test-reports internally?
...and if not strictly required, are there certain markets (e.g. clinical, hospital) that are likely to be looking for them anyway?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
Thanks Marcelo.

For most medical electrical equipment, yes, RoHS and WEEE, and of course either MDD, AIMMD or IVDMM will apply.

From the directives, it appears:
For the RoHS2 (2011/65/EU), there is no particular marking requirement.
For the WEEE (2012-19-EU), a marking with the WEEE is required. If not on the device itself (due to space or function), at least on accompanying packaging, IFU and warranty (see Article 14(4))

Quote:
GS mark (Gepr?fte Sicherheit ("Tested Safety")) or mark to show EN60601-1 compliance (such as the TUV T-mark) are voluntary certification marks. Generally they are not required (one clear case in which such usual voluntary marks are required are the UL components required by the US), but can be used to help fulfill requirements of regulations.
Yes, EN60601-1 compliance goes a long way to fulfill requirements of regulations (side-note: hats-off to any manufacturer that does not go this route! ).
I think there?s some confusion here.

The mark required by WEEE is regulatory requirement which is a label symbol which has a meaning defined in a standard. It?s mandatory due to Article 14 of the regulation.

The certification "marks" are symbols from certification bodies which shows compliance with certification programs run by those certification bodies. The need for a product to have this marking (label symbol) to show compliance with the certification porogram is defined by the certification requirements (and they are usually required anyway).

So

...but my question is specifically regarding marks. If claiming compliance, is such marks on the product required, or is it sufficient just to maintain appropriate test-reports internally?

If you worried about claiming compliance with the mark (meaning, it?s a certification problem), you have to verify if the certification rules requires the marking.

If you are worried about claiming compliance with a standard to show compliance with the regulatory requirement, the mark (certification mark) is not needed (again I,m saying this about certification marks, not the marking required by WEEE, which is mandatory)


...and if not strictly required, are there certain markets (e.g. clinical, hospital) that are likely to be looking for them anyway?
In the case of EU, it depends on the country. The GS mark, I think, may be expected in Germany, even if mandatory. It would be the same case as in the US, in which generally the UL mark is not required for the product itself, but people feel more comfortable with it (and this can get worse because some or all insurance companies won?t insure devices if they do not bear the UL mark).
 

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