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Potential changes to medical device legislation

The UK Government yesterday announced potential changes to medical devices legislation in Great Britain. At present, medical devices placed on the GB market can, until July 2023, be CE Marked under the Medical Devices Regulations 2017/745, or UKCA marked under the UK Medical Devices Regulations 2002.

Details around the potential changes can be found here: https://www.gov.uk/government/news/uk-to-strengthen-regulation-of-medical-devices-to-protect-patients

At the moment, there is no indication of what these Regulations will contain beyond the explanatory note linked above. The CE Marking Association will continue to monitor medical devices regulations in the UK and keep our clients advised as more information becomes available.

If you need any assistance in CE or UKCA marking your medical devices, please contact us at info@cemarkingassociation.co.uk or by telephone on 01564 792349

The CE Marking Association at the Southern Manufacturing Show

It was fantastic to be back at the Southern Manufacturing Show earlier this month where we gave two seminars which looked at the CE Marking process in general as well as exploring recent or imminent changes to legislation and of course, Brexit!.

Members of our Technical Team were on hand to help and advise both before and after the seminars. If you are interested in ongoing support for your CE Marking requirements, we offer membership of the CE Marking Association, details of which can be found here.

We look forward to welcoming you at similar events in the future, please keep an eye on our website for details of future seminars.

A copy of the slides can be found here (File size 3.6Mb)

CE Marking Association Partnership with Croner-i

The CE Marking Association is delighted to announce our Partnership with Croner-i

Brexit has put a lot of additional pressures on businesses, not least on the fields of Product Compliance and Trade & Customs obligations.

As such, we’re pleased to be partnering with Croner-i the UK’s biggest business information provider. Croner-i have been supporting businesses since 1947 and have been recommended by businesses all over the UK, winning the Feefo’s Platinum Trusted Service Award in 2021 for consistently delivering excellence.

As a CE Marking Association member, you’ll get free access to Croner-i’s Trade-inform Lite an exclusive online resource featuring:

  • Weekly updates and e-alerts on the trade industry
  • Trade feature articles and analysis
  • Online toolkits and expert Q&A’s
  • ‘Quick facts’ on exporting and importing topics, focussing in particular on customs and trade tariffs

The ‘Lite’ version of Trade-inform is a great starting point on accessing trade industry news, guidance, and previews of Trade-inform’s full resources. 

Plus, Croner-i is offering CE Marking Association members up to 30% off Croner-i’s Premium packages if you choose to upgrade. This will give you the complete suite of resources that you need to save time and give you peace of mind. Trade-inform gives you the tools to spend less time looking for answers, and more time putting plans into action.

To find out more, please contact the CE Marking Association; info@cemarkingassociation.co.uk or telephone us on 01564 792349

CE Marking Association Annual Seminar 2021

The CE Marking Association’s Annual Seminar was held yesterday (3rd November) with addresses from Oxford Innovations (Formally EGS) and Manufacturing Technology Centre (MTC) as well our guests from the UK Government Department of Business, Energy and Industrial Strategy (BEIS) and a number of our own in-house speakers.

Following the virtual seminar we hosted last year, it was fantastic to be able to meet the majority of our delegates face-to-face however at the same time, we were happy to be able to offer remote access to those unable to travel.

Following the unavoidable last minute cancellation of BEIS in 2019 due to the General Election and Purdah rules, I am glad we were able to offer them a platform to detail how product compliance will shape up as we move forward. They have asked us to thank the seminar for the challenging questions and feedback which they will take back.

We would like to thank all our delegates for attending and hope that you found the day informative and productive. Copies of all of the presentations are now available from within the Members’ area of our website.

If you would like to discuss any of the topics raised, then please call us on 01564 792349

Extension to UKCA Mark Deadline

The UK Government yesterday (24th August) announced an extension to the derogation to allow CE marked products to be placed on the UK market until 31st December 2022.

As such products placed on the UK market (with the exception of Northern Ireland) after 1st January 2023 must carry the UKCA mark.

Details can be found on the UK Government website here.

The CE Marking Association will continue to monitor product compliance legislation, particularly with respect to Brexit and will further update our clients as more information is released.

In the meantime, if you do require any assistance with your CE Marking or UKCA marking requirements, please contact our office on 01546 792349.