P34-35 EU CE UKCA Regulations:Layout 1 28/01/2021 14:57 Page 35 OperatorGuide
To the end-user of a product, the CE marking does not really provide any useful information and should not be used as a quality assurance declaration; it also does not show any evidence of third-party testing. The presence of a CE mark indicates that the appropriate technical documentation that supports the use of the CE mark is available upon request by the manufacturer or the person responsible for placing the product in the EAA. The biggest change to the UK product compliance regime is that the current CE marking will no longer apply in the UK as of 1 January 2022. The UKCA (UK Conformity Assessed) marking system will be the new UK product marking used for those products being sold in the UK market which previously needed a CE mark. At the moment, the UKCA will follow the same guidelines as the CE marking but with safety and compliance standards now being valid in the UK only. Certain products that may only require a self-certification with UKCA and CE laws may, for a short period of time after the transition period, be sold in the UK where they comply with the CE marking.
For those products that are to be sold in the UK which require mandatory third-party assessments to be conducted by notified bodies, such as medical devices, if a UK body has carried out their assessment then the product must be UKCA marked immediately after IP completion. If an EU body has carried out the assessment, then they must have CE markings and will remain accepted for use in the UK as long as the CE mark is accepted, which at the moment is until 31 December 2021.
The new UKCA mark will not be recognised in the EU at any point. However, it can be shown alongside the CE marking and other markings. Therefore, any products that require CE marking and are exported between the UK to the EU will need to meet the EU product standards and be
required to show the CE mark and UKCA mark. There are absolutely no restrictions on products displaying numerous markings as long as they conform to each. UK-based notified bodies which are currently
assigned to assess the conformity of products requiring CE marking before being placed in the EU market will, after the transition, no longer be accepted in the EU. The conformity assessments carried out by them, including those assessments carried out before the end of the transition, will not be valid in the EU. Businesses whose products currently rely on third-party conformity assessments carried out in the UK will need to have new assessments carried out by EU-based notified bodies to ensure continuing compliance. It should also be noted that the UK leaving the EU will affect the supply chain. This is important because, under the EU regulations and the new UK regulations, each operator will have different regulatory obligations, whether they are the manufacturer, importer, or distributor. If the manufacturer from the UK is exporting to the EU, then the receiving country would be considered as the importer. The obligations of an importer are far more serious than that of a distributor, and the obligation is on them to ensure that the products are compliant under the EU regulations. It also applies for EU exporters to the UK: the various importers and distributors must be fully aware of their obligations after Brexit. The divergence now is nothing more than administrative, with both the UK and EU offering different systems but relying on the same health and safety standards throughout. For those businesses hoping to sell products in both the UK and EU markets, both systems must be closely aligned for easy integration; otherwise, it could be a confusing and a financial burden. Businesses should be fully aware of the regulations and new standards that will come into place after 2021, when the transitional
period ends. Brexit negotiations ended shortly before 31st December 2020, and there might be tweaks to the regulations still, but it is recommended to seek legal help where applicable. Hopefully, the transitional period will be smooth, and businesses will be able to trade their goods both in the UK and EU without any issues. The biggest challenge will be complete transparency in the guidelines, ensuring businesses that manufacture, import, or distribute products, are completely clear in their role and what is asked of them within the supply chain.
Source:
https://www.distrelec.ch/en/ knowhow-let-talk-about-brexit-new-compliance- regulations/cms/knowhow-brexit-compliance
The divergence now is nothing
more than administrative, with both the UK and EU offering different systems but relying on the same health and safety standards throughout.
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