April 14th 2020
As you'll no doubt be aware, the UK left the European Union as of 31 January, 2020. Currently the UK is in a ‘transition’ period, which is due to end on 31 December, 2020. We are working to take all necessary steps to ensure that supply of ISC products in to the European Union, remains consistent, as we move in to 2021.
Following the end of the transition period, all CE Certified PPE products sold in to the EU, must bear the mark of a European-based Notified Body. We are now working to change the markings of our PPE products, to bear the Notified Body number 0598 (SGS Fimko), instead of 0120 (SGS UK Ltd.).
After the 31 December, all of the CE Certified PPE products that we supply in to the EU, MUST bear the mark 0598. However, any products marked with the UK Notified Body number 0120, which are already in stock with EU Distributors, will remain valid and can still be sold in the EU market place.
The CE marking procedure is a 2-part process:
Part 1: Technical File
The assessment of the product and supporting technical information (sometimes referred to as the Technical File).
This is conducted by a notified body and when satisfied of the product compliance an EU Type Certificate is issued- this is known as a Module B certificate (formally Article 10 under the PPE Directive 89/686/EEC).
Part 2: Quality System (Module D)
The assessment of the manufacturers quality system- this is referred to as Module D (formally Article 11B under PPE Directive 89/686/EEC). The notified body responsible for assessing the quality system is the notified body referenced on the product.
Currently ISC are assessed for Module D compliance by SGS UK Ltd. (notified body number 0120). This is why you will see CE0120 marked on all ISC products. However, ISC have recently achieved Module D certification from SGS Fimko Oy, (notified body number 0598). ISC will now begin to transition from 0120 to 0598 and you will start to see this new notified body number appearing on our products.
Therefore, over the course of the next few months, you will notice that:
- The notified body number will change from CE 0120 to CE0598, on all of our PPE products
- The Notified Body number will be updated in User Instruction Manuals
- Declarations of Conformity will be updated to show the new CE 0598 number- and we will continue to make CE 0120 Declaration of Conformity documents available (as these will be required, in order to accompany 0120-marked stock which is still in the supply chain)
Our commitment ...
We have started to transition to the new Notified Body number and are continuing to work to complete these changes across the entire range of ISC PPE products, as soon as possible. As of 31 December 2020, all products sold in to the European market by ISC, must carry the new notified body marking CE 0598.
It's IMPORTANT to NOTE:
All 0120-marked stock WILL remain valid, for sale in the EU market, in 2021...
This means that although non-EU manufacturers or distributors will not be able to sell any CE 0120-marked products in to the EU after the 31 December, any 0120-marked products that EU Distributors already have in stock, will remain valid and can still be sold in EU, beyond 31 December 2020.
We will continue to take all appropriate legislative and customer support actions, in order to ensure that supply of products in to the EU will continue as usual, through 2020 and beyond.
If you have any questions, please contact David Rawlins (Technical Sales Manager) by email [email protected], or call +44 (0) 1248 363 125.
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