Entities that are working as manufacturing outfits outside UK / EU need an Authorized Representative for their products in UK/EU.

After Brexit EC issued a notice that states:
“As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the Union. As a consequence, an economic operator established in the EU-27 who, prior to the withdrawal date, was considered as an EU distributor will become an importer for the purposes of Union product legislation in relation to products from a third country that this economic operator places on the EU-27 market as from the withdrawal date. This operator will have to comply with the specific obligations relevant to an importer, which are different from those of a distributor.”

In the UK a ‘Responsible Person’ is required to take the responsibility for the outside UK/EU manufacturer to register the medical equipment related devices in the relevant systems of the authorities. Responsible Person will act as the point of contact for the manufacturer that intend to register that device in UK systems.

Since these can result in lot of implications for the ‘supplier’, Global Standards Assurance (GSA), as an Authorized Representative / Responsible Person, can assist its clients by having an EU / UK address. The address can be used for products being supplied to EU as well as for products being supplied in UK.

Such service will assist GSA clients overcoming many business and regulatory hurdles.