Shipment of goods by parcels from border region to the United Kingdom.

Following the announcement last Friday, January 31, 2020 that the United Kingdom officially ceased to be a member of the European Union, we would like to clarify what the impact is for CE certificates issued by our UK notified body (0086).

The UK has now entered a transition period in which it will negotiate future business and trade agreements with the EU. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently confirmed that, during this transition period, the UK will remain aligned with EU legislation. The transition period will end on Thursday, December 31, 2020.

We will continue to inform you of any changes that may affect CE marking applications for your medical devices or the validity of certificates we have already issued. We invite you to visit our website often for the most up-to-date information.

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In order to be sold in the EU, many products must bear the mandatory CE marking, which shows that the manufacturer has assessed the product and it is deemed to meet EU requirements for safety, health and environmental protection. CE marking is mandatory for products manufactured anywhere in the world that are to be marketed in the EU.

Some products are subject to several EU requirements simultaneously. You must ensure that your product complies with all relevant requirements before affixing the CE marking. It is prohibited to affix the CE marking on products for which there are no EU specifications or which do not require the affixing of the CE marking.

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You should check whether your product needs to be tested by a notified body. You can find this information in the legislation applicable to your product: check the applicable standards per product category.

If your product does not need to be verified by an independent body, it is up to you to check that it meets the relevant technical requirements. This includes estimating and documenting the potential risks arising from the use of the product.

ACTIVITY CERTIFICATE no longer MANDATORY

Read the news article for more information on the validity of accredited management system certificates issued by UK-based conformity assessment bodies following their exit from the EU.

Authorized Representative approval is required under the scope of your CE certification with BSI NL (2797). Changes to your approved CE certification will be required following a review of the representative labels, the Information for Users, the draft Declaration of Conformity and the contract between the manufacturer and the EU Authorized Representative.

Manufacturers located outside the European Union must appoint an Authorized Representative, who must be established in the European Community and explicitly designated to act and be acted upon by the European Community authorities and bodies with respect to the manufacturer’s obligations under the directive.

Approval of the Authorized Representative is required under the scope of your CE certification with BSI NL (2797). Changes to your approved CE certification will be required following a review of the representative labels, the Information for Users, the draft Declaration of Conformity and the contract between the manufacturer and the EU Authorized Representative.

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How long is an electrical certificate valid for uk? 2022

On November 14, the European Union and the United Kingdom reached a withdrawal agreement that establishes the conditions for an orderly exit, pending ratification by the British Parliament as well as by the European Council and the European Parliament.

One of the concerns is the risk that this process may pose in relation to access to medicines: the timing of the procedures will be important both for when they cease to be authorized in the United Kingdom and for the registration processes in this country.

As for the labor aspect, if an association or free trade agreement is signed, the Community regulations governing the Social Security Systems will not be applied, meaning that both European and British citizens will lose their contributions abroad because they would lose the right to benefits and the free movement of workers would disappear, having to request a visa and a specific work permit.

A change in the Social Security system would produce an increase in health insurance costs due to the appearance of new intermediary costs and both European and British citizens would have to pay their medical expenses as they would no longer have European health coverage.

By Rachel Robison

Rachel Robison is a blogger who collects information on court filings and notices.