Is it possible the ERs that you've identified in RED are those essential requirements that are laid out in RED itself?
I agree with Anne that I am not aware of any direct reference in RED to MDD.
See RED Article 3:
Article 3
Essential requirements
1. Radio equipment shall be constructed so as to ensure:
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(a)
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the protection of health and safety of persons and of domestic animals and the protection of property, including the objectives with respect to safety requirements set out in Directive 2014/35/EU, but with no voltage limit applying;
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(b)
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an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU.
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2. Radio equipment shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference.
3. Radio equipment within certain categories or classes shall be so constructed that it complies with the following essential requirements:
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(a)
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radio equipment interworks with accessories, in particular with common chargers;
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(b)
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radio equipment interworks via networks with other radio equipment;
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(c)
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radio equipment can be connected to interfaces of the appropriate type throughout the Union;
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(d)
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radio equipment does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service;
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(e)
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radio equipment incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected;
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(f)
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radio equipment supports certain features ensuring protection from fraud;
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(g)
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radio equipment supports certain features ensuring access to emergency services;
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(h)
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radio equipment supports certain features in order to facilitate its use by users with a disability;
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(i)
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radio equipment supports certain features in order to ensure that software can only be loaded into the radio equipment where the compliance of the combination of the radio equipment and software has been demonstrated.
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Mitchell Boynton
Regulatory Affairs Specialist
Redwood City CA
United States
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Original Message:
Sent: 27-Jan-2022 13:45
From: Anonymous Member
Subject: RED (2014/53/EU) Assessment Compliance Strategy with MDR GSPR
This message was posted by a user wishing to remain anonymous
Hi All,
I am in the process of drafting the RED assessment but it looks like RED refers to the MDD ER's. Do I need to map those ER's against MDR GSPR's and show compliance. I have for some of our MDR TF's they have accepted the compliance strategy with MDD ER. But those were legacy devices. Device that I am working on is new to EU. If anyone can share what they have referred in RED assessment is it ER's or they showed ER and then similar GSPR to show compliance with EU MDR.