Regulatory Open Forum

Hi everyone,

As a manufacturer planning to commercialize a RUO in the EU, I seek clarification on our compliance requirements with the EU RoHS directive. specifically:

- Is it compliance with the EU RoHS directive mandated or recommended for RUO manufacturing processes?

- If mandated, is RoHS3 required, or is RoHS2 sufficient?

- If not mandated, what are the potential advantages to justify adherence to upper management?

Thanks in advance.!

Hi Anon

There are several exclusions described in Article 2, Scope, that might apply to your product, depending on the details. For example, the directive doesn't apply to "equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis."

Hi everyone,

As a manufacturer planning to commercialize a RUO in the EU, I seek clarification on our compliance requirements with the EU RoHS directive. specifically:

- Is it compliance with the EU RoHS directive mandated or recommended for RUO manufacturing processes?

- If mandated, is RoHS3 required, or is RoHS2 sufficient?

- If not mandated, what are the potential advantages to justify adherence to upper management?

Thanks in advance.!

Hi everyone,

As a manufacturer planning to commercialize a RUO in the EU, I seek clarification on our compliance requirements with the EU RoHS directive. specifically:

- Is it compliance with the EU RoHS directive mandated or recommended for RUO manufacturing processes?

- If mandated, is RoHS3 required, or is RoHS2 sufficient?

- If not mandated, what are the potential advantages to justify adherence to upper management?

Thanks in advance.!

To clarify, ours is an Electrical non-medical instruments... an electronic high-resolution microscope. 

Thanks!

Hi everyone,

As a manufacturer planning to commercialize a RUO in the EU, I seek clarification on our compliance requirements with the EU RoHS directive. specifically:

- Is it compliance with the EU RoHS directive mandated or recommended for RUO manufacturing processes?

- If mandated, is RoHS3 required, or is RoHS2 sufficient?

- If not mandated, what are the potential advantages to justify adherence to upper management?

Thanks in advance.!