UKCA FOR MEDICAL DEVICES – UAE, OMAN, SAUDI ARABIA

The UKCA mark is a mark that is utilized for medical devices that are placed within the Great Britain (England, Wales, Scotland) market. The UKCA mark is not recognized in market in the Northern Ireland market.

UKCA For Medical Devices are built on three main types of medical devices as well as their respective Parts of the Medical Devices Regulations 2002 (SI 2002 No 618 (as modified) (UK MDR 2002):

1. General medical devices, Second part of UK MDR 2002
2. Implantable medical devices that are active part III in the UK MDR 2002
3. In out-vitro medical diagnostics (ivds) IV in the UK MDR 2002

You must prove the medical device satisfies the requirements of the UK MDR 2002 by conducting an assessment of conformity. The procedure for assessing depends on the type of device.

You may put an UKCA label on your product to prove it been approved by the UKCA after you have successfully completed the conformity evaluation.

A medical device could be defined as any device or instrument, material apparatus, or other item, which is used in its own form or together with other devices or equipment and software. It is essential and is intended use by the manufacturer for use to treat human beings.

If an approved body was a participant in the assessment of conformity, the identification number of its member must be placed under the UKCA logo.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the body that regulates UKCA certification to medical products. MHRA was established in 2003, and its headquarters are in London. The body offers instructions and guidance on how to register the device using MHRA, as well as conformity markings and certification of the device. 

The regulations in the guidance apply only to GB market i.e., Wales, England, and Scotland. It is important to note that the MHRA will only allow the registration of devices issued by producers or UK responsible persons who are located within the UK.

In the wake of the United Kingdom (UK) leaving the European Union (EU), modifications were enacted for producers who sell their items in the UK market, removing using the CE mark.

CE marks will be accepted as a valid mark by UK for medical devices until June 30th 2023. From that point, manufacturers who want (or plan to) (continue to) offer their products to the UK market must be in compliance with the latest UKCA marking regulations.

UKCA For Medical Devices in UAE, Oman, Saudi Arabia, Kuwait, Qatar, Lebanon, and Jordan requires a third-party evaluation process conducted through a UK Approved Body. This procedure is similar to that used currently by the EU for CE marking, where evaluation of conformity of devices is done by an authorized Notified Body.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the UK’s regulator accountable for ensuring that medications or medical gadgets are secure and efficient.

• Find out what medical device is classified based on Europe’s Medical Device Regulation (MDR).
• Conduct a conformity evaluation to verify the medical device you purchased meets the required safety and performance standards.
• Make a technical document for the medical device you are using, comprising a description of your device, its intended usage, UKCA Certification Cost in UAE as well as any relevant medical data.
• Make your application available to MHRA via their Medical Devices Information System (MDIS).
• The MHRA will review your application and documentation on technical aspects to determine whether your medical device meets the required safety and performance standards.

In the event that your request is accepted If it is approved, your MHRA issues a registered document, which allows you to sell devices for medical use in the UK.

The MHRA has granted a 12-month extension for the upcoming Medical Device Regulations, with the intention of bringing new regulations into effect in July 2024.

Manufacturers can continue to sell CE approved products on the Great Britain market after 1 July 2023.

In July 2024, the transitional arrangement laid in the government’s response to the Consultation regarding the new regulation for devices used in medicine sold in the United Kingdom. It will apply for CE and UKCA certified devices that are placed in the Great Britain market.

The government is planning to present legislation by the spring of 2023, which will put into effect these post-market arrangements and transitional arrangements as well as post-market surveillance regulations as described in the response by the government.

The MHRA has acknowledged the concerns regarding CE UKCA Certification Approved Body capability. The standstill timeframe is expected to allow an additional opportunity to move forward with the application for designation to Approved Bod

Ascent EMIRATES in UAE, Oman, Saudi Arabia, Kuwait, Qatar, Lebanon, and Jordan is one of the UK approved bodies that is specifically geared towards the medical Devices and IVDs. It is the one that is designated for the three kinds of devices covered under UK MDR 2002

• General Medical Devices
• Active Implantable Medical Devices
• In-vitro Diagnostic Medical Devices

As manufacturers, this helps with the accreditation of medical devices. It also will help you manage your product portfolio among various UK Approved Body.

Our team is a unique collection of skills that allow us to give a thorough analysis of your Technical File. You will receive an Ascent Technical Specialist who will assist you throughout your journey to UKCA Certification of your product and will remain your primary point of contact throughout the process.

Ascent EMIRATES provides an edge-to-edge service on a number of ISO Certification in UAE. Connect with us to learn more how you can increase your business standards.