Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS,

What is required to receive support as an SME (small and medium sized enterprise) in Europe?

Is one (1) consultant sufficient or does the company need headquarters in Europe to have a footprint for eligibility?

Thank you

There are two questions here. One is about support and the other is about eligibility. I understand that the EU has programs to support SMEs, but I don't know anything about them.

The other question I about eligibility. Eligibility is based primarily on two factors: annual sales and number of employees. There are other factors also, such as a relationship to parent company.

I've attached the EU document about SMEs. In my EU-MDR course I provide a worksheet to help manufacturers determine their SME status. This is important because it determines whether the manufacturer's Person Responsible must be an employee.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 31-Oct-2019 13:33
From: Anonymous Member
Subject: SME Eligibility

This message was posted by a user wishing to remain anonymous

Dear RAPS,

What is required to receive support as an SME (small and medium sized enterprise) in Europe?

Is one (1) consultant sufficient or does the company need headquarters in Europe to have a footprint for eligibility?

Thank you