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  • Welcome to gainspeed Ltd,

    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

    highly experienced associates.

Category: New Standards/Directives

New Standards

ETSI standards free gap analysis

ETSI have released some extremely useful gap analysis documents for a range of popular ETSI standards. Using these documents it’s a simple exercise identifying important changes that could affect your compliance requirements.

https://portal.etsi.org/Services/editHelp!/Tohelpyouinyourwork/Services/ComparedversionsofETSIHarmonisedStandards.aspx

NOTE:    All the compared versions are available in PDF version

What is Gap Anlaysis?

Gap Analysis for certification is the process of checking your technical file when the standards its certified to have been updated. Then assessing the changes to evaluate if retesting is required.

Why do i need Gap Analysis?

If a company can identify through a gap analysis that retesting is not required it can save a lot of time and money by not repeating the certification process.

Can a Gap Analysis go in my technical file?

Yes it absolutely should, the document can be used as evidence of due diligence when standards change.

What does a Gap Analysis look like?

Gap analysis is generally a report that identifies the changes and summaries its impact. Gainspeed have carried out lots of gap analysis for its clients, please contact us if you would like us to carry out a gap analysis assessment for you today.

 

New Office for Product Safety and Standards in the UK

The government has today (21 January 2018) announced the creation of a new national oversight body tasked with identifying consumer risks and managing responses to large-scale product recalls and repairs.

The new Office for Product Safety and Standards will enable the UK to meet the evolving challenges of product safety by responding to expanding international trade, the growth in online shopping and the increasing rate of product innovation.

Today’s announcement comes as part of the government’s response to the Working Group on Product Recalls and Safety. Established in October 2016 by former Consumer Minister Margot James, the group of product and fire safety experts was brought together to build on the recommendations made by Lynn Faulds Wood in her independent review into consumer product recalls.

In addition to providing support and advice for local authority Trading Standards teams, the office will co-ordinate work across local authorities where action is needed on a national scale and will ensure the UK continues to carry out appropriate border checks on imported products once the UK leaves the European Union.

Business Minister Andrew Griffiths said:

The new Office for Product Safety and Standards will strengthen the UK’s already tough product safety regime and will allow consumers to continue to buy secure in the knowledge there is an effective system in place if products need to be repaired or replaced.

I thank the working group for their efforts to help improve product safety and I look forward to working with them in this new phase.

Neil Gibbins, Chair of the working group, said:

It has been my mission to make the public safe since I joined the fire service nearly 40 years ago. That’s why I’m pleased to see the government respond to our recommendations with concrete steps to ensure the safety of consumers, now and in the future.

The government will continue to work with stakeholders such as consumer groups, manufacturers and retailers to ensure the office coordinates the UK’s product safety regime as effectively as possible.

This will not lessen any of the legal responsibilities that sit with manufacturers, importers and retailers to present safe products to the market, and to take rapid effective action when safety issues arise with their products.

Other actions as part of the government’s response to the working group include:

  • working with the British Standards Institution to provide guidance on product recalls and corrective action
  • conducting research to help manufacturers and retailers develop technological solutions to product marking and identification
  • increasing the reach of Primary Authority to further share business, local authority and Department for Business, Energy and Industrial Strategy (BEIS) expertise to help protect consumers
  • researching consumer behaviour to identify the best way to drive up the number of consumers registering appliances with manufacturers
  • creating an expert panel to bring together trade associations, consumer and enforcement representatives to advise on product safety issues as they arise

Notes for editors

  1. The office will be based in the Department for Business, Energy and Industrial Strategy (BEIS) and will start work immediately.
  2. It will work closely with the BEIS Chief Scientific Advisor, Professor John Loughhead, to ensure it has access to cutting-edge scientific and technical expertise.
  3. The Working Group on Product Recalls and Safety was set up by former Consumer Minister Margot James to provide recommendations to improve the recalls process and the safety of consumer products. The group published its report in July 2017.
  4. The Office for Product Safety and Standards will cover general (non-food) consumer product safety. It will not cover vehicles, medicines and medical devices, or workplace equipment, which are already covered by other agencies. This remit is in line with the current responsibilities of BEIS on product safety.
  5. The remit of the office does not cover construction products, which are currently subject to a separate review being led by Dame Judith Hackitt. The government will carefully consider the recommendations of that review when it concludes.
  6. The Office for Product Safety and Standards will have a budget of around £12 million per year when fully operational.
  7. There are no changes to the roles and responsibilities of local authorities or other market surveillance authorities. The office will provide a number of specialist services centrally to support consistent national enforcement, including aspects of product testing and technical expertise.
  8. Primary Authority enables businesses to form a legal partnership with one local authority, which then provides assured and tailored advice on complying with environmental health, trading standards or fire safety regulations that other local regulators must respect.

Link to original article on gov.co.uk https://www.gov.uk/government/news/government-launches-new-office-for-product-safety-and-standards

 

 

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.

“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.