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    CE Marking Specialists


    A South Wales based Product  Certification and training company, specialising in supporting small to medium enterprises in meeting their CE Marking obligations


  • Specialists in EMC and Low Voltage

    (Safety) Directives


    We specialise in European and Worldwide approvals.

  • Flexible, Professional, and Affordable Service


    We are a small organisation employing only

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Category: News

“Economic operator” required for UK imports into the EU from 16th July 2021

EU Regulation on Market Surveillance and Compliance of Products 2019/1020 applies in the EU from 16 July 2021. 019/1020 replaces the market surveillance provisions in the Regulation and Accreditation Market Surveillance 765/2008 (RAMS).

Overview

Until now, sales where the Business is located outside of the EU and the Customer is in the EU were not regulated. Because there was no legal entity formally responsible for the regulatory compliance of products bought outside the EU.

From July 16th this year, non-EU vendors will have to have an EU authorised representative/economic operator to sell most products to EU customers. The Market Surveillance Regulation lays down rules according to which the fulfilment service provider will be kept responsible when the non-EU vendor doesn’t appoint a responsible person.

Economic Operator

This can be an authorised representative, manufacturer, importer or fulfilment service.

Responsibilities

Keep and provide a Technical File with all the relevant conformity and performance information. Notify risk to the market surveillance authority if it arises. Cooperate with market surveillance authorities requests.

Labelling and contact details

The name and contact details of the responsible economic operator must be indicated on the product or on its packaging, the parcel or an accompanying document.

Risk Assessment

New IEC 62368-1 Audio/video, information and communication technology equipment – Part 1: Safety requirements.

On December 20, 2020, products on the market will need to meet the requirements of the new IEC 62368-1 standard; previous standards IEC 60950-1 and IEC 60065, and their regional harmonized standards, will be formally withdrawn. This is not a merger of IEC 60950-1 and IEC 60065 but a completely new standard applicable to products in its scope. Compliance criteria for the standard is related to hazards for performance and construction.

As an EN Harmonized standard, it should be used in compliance against the LVD (Low Voltage Directive) for CE Marking purposes within Europe.

Disclaimer:

This document is provided for information purposes only and does not replace the need to obtain further independent advice and/or to instruct/appoint a notified or competent body or person(s) to carry out further investigation and/or testing. National and International Regulations are constantly changing and evolving. Accordingly, no warranty is given, nor is any term or condition to be implied, that the information provided in this document is accurate and that it eliminates the need for seeking further advice or investigation.

Gainspeed Newsletters 2019 issue 3

New Harmonised Standards lists published in the OJEU plus more news on Brexit.

Have questions? We can help, feel free to contact us

Some of this months features are.

This issue:
Headlines
Standards Watch
European standards being withdrawn
Other standards being withdrawn
Lists of European Harmonised Standards
Regulatory Standards Roadmap
Machinery Directive
Where have all the standards gone?
Brexit
Product standards and safety marking
Environmental
RoHS Directive
New / updated Standards – details of changes
draft EN 303 446-1 V1.2.0
draft EN 303 446-2 V1.2.0
BS EN 55011:2016+A1:2017
New Quality Management System Policies
SBD Electronics Laboratory policy and working practices
ASME Information
“Standards & Certification Update”:
New Standards Published
April 2019
May 2019
June 2019
Compliance Calendar

Download

View Online

2019-07-10 12:25:36
Posted in News, News Letter |

Gainspeed Newsletter 2019 issue 4 (revised)

REACh adds new substances, and the Machinery Directive mystery is solved.

Headlines
Standards Watch
European standards being withdrawn
Other standards being withdrawn
Lists of European Harmonised Standards
Update on Harmonised Standards Lists
Change to the process for publication in the OJEU
EMC Directive (2014/30/EU)
Machinery Directive (2006/42/EC) – correction
REACH
Update to Candidate List
Update to Restricted List
Guidance
PD IEC TR 62368‑2:2019
New Standards Published
June 2019
July 2019
August 2019
Compliance Calendar

Download

View Online

2019-09-06 11:46:30
Posted in News, News Letter |

IEC 61326-1: 2019 (CDV) Electrical equipment for measurement, control and laboratory use. Notes/Summary of Changes

Background

CISPR document 65A/922/CDV (IEC 61326 Ed 3) has been distributed to National Committees for comments with closing date 15/11/2019. If adopted without amendments, IEC 61326-1: 2019 Includes the following significant technical changes with respect to IEC 61326-1: 2013.

Changes

  • Emissions: Group and classes now apply as laid out in CISPR 11:2015/AMD 1:2016/AMD2:2019. For CLASS B EQUIPMENT with input current up to 16 A, IEC 61000-3-2 and IEC 61000-3-3 apply. For higher input currents up to 75 A per phase IEC 61000-3-12 and IEC 61000-3-11 apply as before
  • Electrostatic Discharge: No Significant changes
  • Electromagnetic field: Now requires 3V/m from 1.4GHz to 6GHz for basic and industrial environments. Originally this was 1V/m from 2GHz to 2.7GHz. This also considers battery operated devices as in Annex A
  • Voltage Dips: No longer required for controlled environments when applied to AC power (including protective earth)
  • Power frequency magnetic field: No Significant changes
  • Burst:  Optional 5KHz or 100KHz
  • Surge No Significant changes
  • Conducted RF No Significant changes
  • Instructions for use (NEW) The manufacturer shall give information that emissions, which exceed the levels required by this standard, can occur when equipment is connected to a test object.

Update DOC without testing?

No!

New requirement for Radiated Immunity above 1GHz.

Previous tests would have been done at 1V/m for 2GHz to 2.7GHz. Requirement has changed to 3V/M from 1.4GHz to 6GHz. Manufacturers should either consider retesting to the new level or carry out a risk assessment.

Disclaimer:

This document is provided for information purposes only and does not replace the need to obtain further independent advice and/or to instruct/appoint a notified or competent body or person(s) to carry out further investigation and/or testing. National and International Regulations are constantly changing and evolving. Accordingly, no warranty is given, nor is any term or condition to be implied, that the information provided in this document is accurate and that it eliminates the need for seeking further advice or investigation.

Posted in News, Uncategorized |