“For legislations, please use the link: legislation.gov.uk This webpage is the official one for all enacted legislations in the UK and will have the updated regulations. To know if a Standard has been harmonized by the UK, you need to look for the acronym BS (British standard). Is the standard is not yet harmonized, then the use of the international one is not a problem. Please remember that in the list of applied standards, the UK will expect that the BS harmonized standards be included in the list.”

“Yes, the distributor or importer can act as the UK Responsible Person as long as they are subscribed on the MHRA (Medicines and Healthcare Regulatory Agency) registration system. Please remember that a contract between the manufacturer and the UK Responsible Person, detailing the responsibilities and requirements, needs to be signed. The contract needs to be between this both parties, no intermediary agency should be included. Also remember that there can only be 1 UK Responsible Person per legal manufacturer.”

“The question has to do with the definition of “placing of the market”. To answer the question, you do not need to affix a UKCA mark, nor register the product under UK law if the product was sold before the deadline of 01.07.2024 and the product already is CE marked.

A product is placed on the market when an offer or agreement is made for the transfer of ownership, possession or any other property right. It does not require the physical transfer of the product. Nevertheless please remember that the product needs to be fully manufactured before sending, since this does not applies to unfinished products.

Proof that a product has been placed on the market include documents typically used in business transactions, for example:

• contracts of sale for goods
• invoices
• shipping documents for goods

“Yes, there are exceptions to be taken into consideration for the UKCA label.

They are as follow:

• the mark is not applied where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and
• It is allowed to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility”