Regulatory Open Forum

Hi everyone, 

I would appreciate your help and guidance on this. 

1. Does any one know what are the requirements  for completing electromagnetic compatibility assessment for module A instrument, ANNEX-II (2) OF 2014/30/EU directive?
2. If we sign the Declaration of Conformity, can we immediately affix the CE mark, or is there a specific process that we need to follow? Do we need to register the instrument locally? 

Thanks. 

First I'd like to ask if the instrument is either a medical device or IVD?  If so, then Europe's Regulations 2017/745 or 2017/746 are lex specialis (take precedence over) Directive 2014/30/EU.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Jan-2024 08:10
From: Anonymous Member
Subject: CE-MARKING Electromagnetic Compatibility Directive EMC 2014/30/EU

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would appreciate your help and guidance on this. 

1. Does any one know what are the requirements  for completing electromagnetic compatibility assessment for module A instrument, ANNEX-II (2) OF 2014/30/EU directive?
2. If we sign the Declaration of Conformity, can we immediately affix the CE mark, or is there a specific process that we need to follow? Do we need to register the instrument locally? 

Thanks. 

Hello Anon,

Kevin is correct if the device is a medical device than the Regulations with the associated IEC standards would be applicable - such as IEC 60601-1-2.  If the product is not a medical device then EMC (commonly now referred to as Electromagnetic Disturbance [EMD] testing) is done according to the IEC 61000 suite of standards.  Following on this is the product is not a medical device, then once the testing is done, the Declaration of Conformity can be generated because this is a self declaration.  Though if a medical device, there may be alot more involved depending on the class and conformity assessment route.  The Directive itself is fairly vague and high-level, but there are EMD/EMC testing standards which are available such as the IEC standards mentioned.

First I'd like to ask if the instrument is either a medical device or IVD?  If so, then Europe's Regulations 2017/745 or 2017/746 are lex specialis (take precedence over) Directive 2014/30/EU.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Jan-2024 08:10
From: Anonymous Member
Subject: CE-MARKING Electromagnetic Compatibility Directive EMC 2014/30/EU

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would appreciate your help and guidance on this. 

1. Does any one know what are the requirements  for completing electromagnetic compatibility assessment for module A instrument, ANNEX-II (2) OF 2014/30/EU directive?
2. If we sign the Declaration of Conformity, can we immediately affix the CE mark, or is there a specific process that we need to follow? Do we need to register the instrument locally? 

Thanks. 

Hi @Richard Vincins & @Kevin Randall, 

Our intention is to obtain a CE mark for this instrument, categorizing it as a laboratory instrument similar to a clinical chemistry analyzer. The intended use is broad and not specifically linked to any particular IVD testing.

Crucially, we do not have plans to sell this analyzer in the European market. Its design is tailored to complement our in-house testing , which is currently under development. Once this testing is finalized, it will be labeled as RUO. Subsequently, we aim to distribute it to research centers alongside the CE-marked analyzer. SO it will be CE- analyser with RUO testing. 

Hope this makes sense. 

I really appreciate every insight and advice on this. 

Thanks. 

Hello Anon,

Kevin is correct if the device is a medical device than the Regulations with the associated IEC standards would be applicable - such as IEC 60601-1-2.  If the product is not a medical device then EMC (commonly now referred to as Electromagnetic Disturbance [EMD] testing) is done according to the IEC 61000 suite of standards.  Following on this is the product is not a medical device, then once the testing is done, the Declaration of Conformity can be generated because this is a self declaration.  Though if a medical device, there may be alot more involved depending on the class and conformity assessment route.  The Directive itself is fairly vague and high-level, but there are EMD/EMC testing standards which are available such as the IEC standards mentioned.

First I'd like to ask if the instrument is either a medical device or IVD?  If so, then Europe's Regulations 2017/745 or 2017/746 are lex specialis (take precedence over) Directive 2014/30/EU.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Jan-2024 08:10
From: Anonymous Member
Subject: CE-MARKING Electromagnetic Compatibility Directive EMC 2014/30/EU

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would appreciate your help and guidance on this. 

1. Does any one know what are the requirements  for completing electromagnetic compatibility assessment for module A instrument, ANNEX-II (2) OF 2014/30/EU directive?
2. If we sign the Declaration of Conformity, can we immediately affix the CE mark, or is there a specific process that we need to follow? Do we need to register the instrument locally? 

Thanks.