UKCA FOR IVD – UAE, OMAN, SAUDI ARABIA

Manufacturers can make use of this UKCA label on a non-committal basis up to the 30th of June 2030. CE medical devices that are CE marked are able to continue to be used in the Great Britain, market, with the timeframe for acceptance dependent on the kind of device as well as the regulations it conforms to. 

The latest date for these deadlines is June 30, 2030. Devices that are used to evaluate performance don’t need to be UKCA certified.

A manufacturer is not allowed to use the UKCA label until they have met the requirements of the UK MDR 2002. The UKCA for Medical Devices and IVDS mark therefore is interpreted as a statement by the manufacturer that the product is in compliance with all applicable requirements of relevant laws, including those related to safety. A product that bears a UKCA label can be sold within Great Britain (England, Wales and Scotland). However, it is not recognized by the EU, EEA or Northern Ireland markets.

Products that are sold within markets in the EU, EEA or Northern Ireland are still required to have CE marking except for exemptions. An CE UKNI mark can be applied for the purpose for Northern Ireland, but this device is not able to be sold on the EU or EEA markets.

The UKCA label must be placed in a legible, visible and permanent form to the product (where feasible and necessary) and on the directions to usage. It should also be visible on the sales package. The appropriate UK authorized body identification number (where one is utilized) should be included with the UKCA label.

The UK MDR 2002 is not applicable only to devices available for sale, however, it also applies for devices put in service and are used as part of a professional endeavor and are not placed in the marketplace. This is a provision that covers testing kits that are manufactured and utilized by commercial or different testing services that they employ in-house; however they do not sell their products on sale.

The UK MDR 2002, Regulation 2 defines an UKCA For IVD as a medical device:

1. As a reagent or product or calibrator kit, instrument equipment, or system, whether it is used as a whole or in conjunction with other equipment or systems; and
2. As designed for its manufacturer used in vitro to the examination of specimens which include blood and tissue donations derived from the human body exclusively or primarily to provide the following information:

• • • In relation to an underlying physiological or pathological condition
    • In relation to a congenital abnormality
    • To assess the safety and compatibility of the donated material that include blood and other donated tissue, recipients or
    • To monitor therapeutic actions and includes a sample receptacle, but is not a product designed for general laboratory use unless the product, based on its features, is made by its maker to be used for an in the laboratory diagnostic examination in.

In contrast, Regulation 33 exempts ‘health institutions’ from the requirements that are in UK MDR 2002 in certain conditions:

The conditions of this part are in regard to devices relevant to them, are applicable for the in-vitro medical diagnostic devices as well as accessories to them with the exception of products.  These are made and used in the same health establishment or on the premises of their production or on premises within the immediate vicinity, without being transferred to a legally constituted entity.

• Medical devices for general use – up to the expiration date of the certificate or until three years following the date that the new regulations come into effect (whichever occurs earlier) and
• In-vitro Diagnostics (IVDs) up to either the certificate expires, or 5 years following the date that new rules go into effect (whichever is later).)

The transitional provisions will not be applicable in the event of significant modifications to the design or intent that the gadget is intended for. In addition, all UKCA For IVD in UAE, Oman, Saudi Arabia, Kuwait, Qatar, Lebanon, and Jordan devices which will benefit from transitional arrangements must meet post-market requirements.

IVDs must be in compliance with the requirements of the industry before they can be released for sale (Part IV of UK MDR 2002 Annex I [as amended in Part III of the Schedule 2A of the UK MDR 2002[as modified by Part III of Schedule 2A to the UK MDR 2002]).

The primary requirements are designed to ensure that the devices don’t compromise the safety and health of users or patients. They are manufactured and designed to meet the specifications set by the manufacturer to meet the intended medical use. The essential UKCA Marking in IVD in UAE, Oman, Saudi Arabia, Kuwait, Qatar, Lebanon, and Jordan requirements may not be met in all cases, are applicable to all devices. It is the responsibility of those who manufacture the product to determine the appropriateness of their specific product.

One method by which manufacturers can show that they’ve met the necessary requirements is by ensuring that they meet the applicable standards that have been specified to The UK MDR 2002.

Ascent, as our internal regulatory team, have worked with our manufacturing and lateral flow development clients to develop their tests in preparation for UKCA Certification for a long time. Furthermore, it has gained vast knowledge and experience in global approval and regulatory processes.

We offer full-service support for the creation of your technical dossier and manage clinical trials. We can also as the UK Responsible Person and ensure that post-market surveillance is implemented. No matter where your IVD is at its point in its life and whether it is a lateral flow device, other methods. Contact us to find out how we can assist.

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