UKCA Marking

Dear Member,

In the letter sent to our Chamber by TOBB, with reference to the letter dated 07.09.2022 and numbered 858637 received from the Turkish Medicines and Medical Devices Agency. The letter referenced below provides information on the matters to be considered and the requirements for exporting medical devices to the United Kingdom.

"As is known, the United Kingdom (UK) left the European Union (EU) as of 31 January 2020. The transition period that started after the departure also ended on 1 January 2021. Since 1 January 2021, the requirements to be fulfilled and the rules to be complied with when placing products on the UK market have shown certain differences for product groups. In the UK, from 1 January 2023, the application of the UKCA (UK Conformity Assessed) marking, which will replace the CE marking, will begin. With an announcement made by the UK on 20 June 2022, facilitating measures for the business world regarding the application of the UKCA marking for certain product groups, excluding medical devices, were announced. The announcement text and the guidance document on the subject can be accessed at the addresses below.

-https://www.gov.uk/government/news/government-to-make-it-simpler-for-businesses-to-applynew-product-safety-markings

-https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-great-britain

The list of the product groups to which the said flexibilities will apply and of the other product groups to which the flexibilities will not apply and which will be subject to special arrangements is included in the explanatory texts linked above. Medical devices are among the product groups that will be subject to the said special arrangements.

However, the CE marking will continue to be recognised in Great Britain until 30 June 2023. Certificates issued by Notified Bodies recognised by the EU will remain valid for the Great Britain market until 30 June 2023. However, from 1 July 2023, in order for medical devices to be placed on the market in the UK, they will be required to bear the UKCA marking affixed in accordance with UK MDR 2002.

In addition, in order for medical device manufacturers in our country to be able to export medical devices to the UK;

• they are required to appoint an authorised representative established in the UK (UK Responsible Person),
• and to register, through the authorised representative they appoint, with the MHRA, the competent authority in this field, all medical devices they will place on the market in the UK, including in vitro diagnostic medical devices, system and procedure packs and custom-made devices.

Furthermore, you will be able to access detailed information on the UK's Medical Devices Regulations and the UKCA marking via the link https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk"

Kind regards,

Elazığ Chamber of Commerce and Industry

 

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Date Added :2022-09-15 02:58:00