Exemption Clauses for Research, Demonstration, etc.

Mark Meer

Trusted Information Resource
#1
Hello All,

I am hoping to compile in one place references to various exemption clauses, that allow for regulation exemptions in cases of, for example, devices used for research/investigative purposes, or demonstration/trade-fair purposes.

This thread could also be used to discuss the specific requirements for any such exemptions.

So far, I just have the following 2 references:

United States:
21 CFR 812, Investigational Device Exemptions

EU:
MDR (EU 2017/745), Article 21

Australia:
Don't know the specific regulations, but this page gives links to various policies and frameworks regarding unapproved devices.


Does anyone know if there are similar exemptions in other countries' regulations (Brazil, Canada, ...)?
 
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Mark Meer

Trusted Information Resource
#2
To expand on this thread, perhaps it'd be helpful to narrow to the following scope: 2 possible exemptions:
  1. Investigational/Research
  2. Demonstration/Trade-Fair
Given this, I'd be helpful to be able to fill in the following list:

Market: USA
Investigational/Research Exemption: Yes (21 CFR 812, Investigational Device Exemptions)
Demonstration/Trade-Fair Exemption: ???

Market: EU
Investigational/Research Exemption: Yes (MDR Article 21 (1))
Demonstration/Trade-Fair Exemption: Yes (MDR Article 21 (3))

Market: Canada
Investigational/Research Exemption: Yes (Investigational Testing Authorization)
Demonstration/Trade-Fair Exemption: ???

Market: Australia
Investigational/Research Exemption: ???
Demonstration/Trade-Fair Exemption: ???

Market: Brazil
Investigational/Research Exemption: ???
Demonstration/Trade-Fair Exemption: ???

...
 
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