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NIST TEL MRA Program Office

Notified Body Reporting/Information Obligations

& 

Annual Reporting Obligations to NIST

(This document also addresses record retention and monitoring obligations)

EMC Directive 2014/30/EU & Radio Equipment Directive 2014/53/EU

Version 3.0 - 01/08/2020

This document has been prepared by NIST to help NBs understand and comply with the 

reporting/information obligations in the EMC and Radio Equipment Directives.

For the monitoring obligations – please refer to page 4 of this document. 

EMC Directive

2014/30/EU

Radio Equipment Directive 

2014/53/EU

NIST Instructions Applicable to NBs

Article 34 Article 36

1. Notified bodies shall inform the 

notifying authority (NIST) of the 

following

1. Notified bodies shall inform the 

notifying authority (NIST) of the 

following

a) any refusal, restriction, suspension 

or withdrawal of a certificate;

a) any refusal, restriction, suspension 

or withdrawal of an EU-type 

examination certificate [or a quality 

system approval] in accordance 

with the requirements of Annexes 

III [and IV];

NBs shall provide this information to 

NIST on an annual basis, by no later 

than January 31 of each year, for the 

NB activities conducted during the 

prior year (from January 1 to 

December 31). 

 

b) any circumstances affecting the 

scope of or conditions for 

notification;

c) any circumstances affecting the 

scope of or conditions for 

notification;

Notify NIST via mra@nist.gov when 

relevant. For example, if the 

accreditation is no longer valid. 

c) any request for information which 

they have received from market 

surveillance authorities regarding 

conformity assessment activities;

d) any request for information which 

they have received from market 

surveillance authorities regarding 

conformity assessment activities;

Notify NIST via mra@nist.gov as soon 

as NB is contacted by a Market 

Surveillance Authority. 

d) on request, conformity assessment 

activities performed within the 

scope of their notification and any 

other activity performed, including 

cross-border activities and 

subcontracting.

e) on request, conformity assessment 

activities performed within the 

scope of their notification and any 

other activity performed, including 

cross-border activities and 

subcontracting.

NBs shall respond to NIST requests 

for this information in a timely 

manner (within 30 days). 
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EMC Directive

2014/30/EU

Radio Equipment Directive

2014/53/EU

NIST Instructions

2. Notified bodies shall provide the 

other bodies notified under this 

Directive carrying out similar 

conformity assessment activities 

covering the same apparatus with

relevant information on issues 

relating to negative and, on request, 

positive conformity assessment 

results

2. Notified bodies shall, in accordance 

with the requirements of Annexes 

III and IV, provide the other bodies 

notified under this Directive 

carrying out similar conformity 

assessment activities covering the 

same categories of radio 

equipment with relevant 

information on issues relating to 

negative and, on request, positive 

conformity assessment results.

NBs must participate in the NB 

Certificate Database process as 

required for NBs by the EUANB and 

the REDCA. This is mandatory. 

NBs shall address their participation 

in the NB Database in their NB 

procedures. 

NBs shall follow the appropriate 

EUANB and REDCA Procedures for NB 

Certificate Database participation.

NBs shall disclose their participation 

in the NB Database to their clients in 

the client contract/agreement. 

For further information, please see 

the following documents: 

EUANB 

EUANB (16) 018 – NB Certificate 

Database for Module B/C 

Assessments According to EMCD 

2014/30/EU

EUANB (16) 018a – Form to Acquire 

Access Rights to NB Certificate 

Database

REDCA 

REDCA (18) 32 – Draft - RED NB 

refused Certificate Database process 

For Module B assessments according 

to RED 2014/53/EU

REDCA (17) 26a Form to Acquire 

Access rights to REDCA NB Certificate 

Database (updated April 2018)

NOTE 

NIST does NOT have access to 

database information. This is a 

confidential tool to be used by NBs 

only. 
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EMC Directive

2014/30/EU

Radio Equipment Directive

2014/53/EU

NIST Instructions

Annex III (8) Annex III (8) 

Paragraph 1

Each notified body shall inform its 

notifying authority (NIST) concerning the 

EU-type examination certificates and/or 

any additions thereto which it has issued 

or withdrawn... 

Paragraph 1

Each notified body shall inform its 

notifying authority (NIST) concerning the 

EU-type examination certificates and/or 

any additions thereto which it has 

issued or withdrawn....

NBs shall provide this information to 

NIST on an annual basis, by no later 

than January 31 of each year, for the 

NB activities conducted during the 

prior year (from January 1 to 

December 31). 

....and shall, periodically or upon request, 

make available to its notifying authority

the list of such certificates and/or any 

additions thereto refused, suspended or 

otherwise restricted.

....and shall, periodically or upon 

request, make available to its notifying 

authority the list of such certificates 

and/or any additions thereto refused, 

suspended or otherwise restricted.

NBs shall provide this information to 

NIST on an annual basis, by no later 

than January 31 of each year, for the 

NB activities conducted during the 

prior year (from January 1 to 

December 31). 

Paragraph 2

Each notified body shall inform the other 

notified bodies concerning the EU-type 

examination certificates and/or any 

additions thereto which it has refused, 

withdrawn, suspended or otherwise 

restricted, and.... 

 

Paragraph 2

Each notified body shall inform the 

other notified bodies concerning the EUtype examination certificates and/or any 

additions thereto which it has refused, 

withdrawn, suspended or otherwise 

restricted, and, 

NBs must participate in the NB 

Certificate Database process as 

required for NBs by the EUANB and 

the REDCA. This is mandatory. 

 

NBs shall address this requirement in 

their procedures and shall disclose 

this requirement to the clients in 

client contract/agreement.

....upon request, concerning such 

certificates and/or additions thereto 

which it has issued.

upon request, concerning such 

certificates and/or additions thereto 

which it has issued.

NBs shall provide this information to 

other notified bodies upon request. 

Paragraph 3 Paragraph 3

Each notified body shall inform the 

Member States of EU-type examination 

certificates it has issued and/or 

additions thereto in those cases where 

harmonized standards the references of 

which have been published in the 

Official Journal of the European Union 

have not been applied or not been fully 

applied. 

This requirement applies to the RED 

NBs only.

NBs shall follow the procedure 

established by the REDCA: 

ADCO RED has made available the 

following non-person specific email 

address that should be used to 

submit this information to one 

address (to ADCO RED) instead of 

having to separately provide the 

information to each Member State 

National Authority:

ADCO-RED@bakom.admin.ch

[Reference: REDCA (18) 48] 
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EMC Directive

2014/30/EU

Radio Equipment Directive

2014/53/EU

NIST Instructions

The Commission, the Member States and 

the other notified bodies may, on 

request, obtain a copy of the EU-type 

examination certificates and/or additions 

thereto. 

The Member States, the Commission and the 

other notified bodies may, on request, obtain a 

copy of the EU-type examination certificates 

and/or additions thereto. 

Provide upon request to the 

requesting party. 

On request, the Commission and the 

Member States may obtain a copy of the 

technical documentation and the results 

of the examinations carried out by the 

notified body.

On request, the Member States and the 

Commission may obtain a copy of the technical 

documentation and the results of the 

examinations carried out by the notified body. 

Provide upon request to the 

requesting party. 

The notified body shall keep a copy of the 

EU-type examination certificate, its 

annexes and additions, as well as the 

technical file including the 

documentation submitted by the 

manufacturer, until the expiry of the 

validity of that certificate.

The notified body shall keep a copy of the EUtype examination certificate, its annexes and 

additions, as well as the technical file including 

the documentation submitted by the 

manufacturer for 10 years after the radio 

equipment has been assessed or until the expiry 

of the validity of that certificate.

NBs must define in their own 

terms when the EU Type 

Examination Certificate 

expires. 

One option is to include an 

expiration date. However, 

even if this is included - at any 

time that either the technical 

requirements or the product 

changes, the EU Type 

Examination Certificate may 

no longer be valid. Some of 

the relevant requirements for 

monitoring obligations are 

included at the end of this 

table. 

RED NBs must address the 10 

year record retention date in 

the NB procedures. 
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NB MONITORING OBLIGATIONS

NBs and the client manufacturers have on-going obligations to each other to ensure that the EU Type Examination 

Certificates that are issued continue to remain valid for products being placed on the market in the EU. 

Relevant Requirements in the EMC Directive

EMC D – Annex III (7) 

The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art {NIST 

Comment –Track standards development activities} which indicate that the approved type may no longer comply 

with the applicable requirements of this Directive and shall determine whether such changes require further 

investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type 

examination certificate of all modifications to the approved type that may affect the conformity of the apparatus 

with the essential requirements of this Directive or the conditions for validity of that certificate. Such modifications 

shall require additional approval in the form of an addition to the original EU-type examination certificate. {NIST 

Comment – Require this of client in the contract.}

EMC Directive Article 32 

4. Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds 

that an apparatus no longer complies, it shall require the manufacturer to take appropriate corrective measures 

and shall suspend or withdraw the certificate if necessary.

5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, 

suspend or withdraw any certificates, as appropriate

{NIST Comment – Enter information into the NB Certificate Database.}
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Relevant Requirements in the Radio Equipment Directive

RED Annex III

7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art {NIST 

Comment – Track relevant standards development activities] which indicate that the approved type may no longer 

comply with the applicable requirements of this Directive and shall determine whether such changes require further 

investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type 

examination certificate of all modifications to the approved type that may affect the conformity of the radio 

equipment with the essential requirements of this Directive or the conditions for validity of that certificate. Such 

modifications shall require additional approval in the form of an addition to the original EU-type examination 

certificate {NIST Comment – Require this of client in the contract}

RED Article 34 (4)

4. Where, in the course of the monitoring of conformity following the issue of an EU-type examination certificate 

or a quality system approval, a notified body finds that radio equipment no longer complies, it shall require the 

manufacturer to take appropriate corrective measures and shall suspend or withdraw the EU-type examination 

certificate or the quality system approval if necessary.

5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, 

suspend or withdraw any EU-type examination certificates or quality system approvals, as appropriate.

{NIST Comment – Enter the relevant information into the NB Certificate Database.}

Revision Notes for Version 3.0 (January 8, 2020)

- Removed 2018 NB reporting due date

- Removed highlights from text