UKCA FOR GAP ANALYSIS – UAE, OMAN, SAUDI ARABIA

It is a new marking for UK products. UKCA mark is a fresh UK label of conformity to the product used to mark products that are sold within the GB market (England, Scotland and Wales). It is applicable to most items, that previously required the CE marking. The new label began to take effect on January 1st 2021. However, sellers of CE certified products in the UK may delay certification to the UKCA certification until 2023’s expiry date.

Be aware that the European Commission doesn’t recognise the UKCA marking, and as such products with only the UKCA mark aren’t permitted to be sold through the EU market.

The UKCA marking will become mandatory for all products that are sold through the GB market starting in January 2023.

But, you may require this new marking prior to the 20th of January 2023, if certain conditions are applicable to you. In this case, the product you are selling must be UKCA marking-compliant if the following are applicable:

• This product is designed meant for sale in Great Britain,
• It is within the scope of UKCA statute,
• It was required to conduct a third-party conformity assessment
• And the conformity evaluation is performed by an assessment body that is recognised in the UK.

Be aware that the above UKCA for Gap Analysis requirements are not applicable to products that have already been manufactured, CE marked and ready to go onto the GB market prior to the beginning of January 2021. These products, however, must be put onto the marketplace within Great Britain before 31 December 2022. In any case, compliance with UKCA law is required.

Marking cannot be used to market products in market in the Northern Ireland market, and your products have to bear both the CE mark or UKNI marking.

Gap analysis’ may be defined in various ways, based on the situation. For our purposes, the gap analysis is the most effective and cost-effective method to allow MedTech firms to sustain the quality of their processes. 

It’s a formal, comparative analysis of a procedure or process in relation to the standard, best practice, regulation, etc. The UKCA for Gap Analysis assessment also assists companies decide which tools to employ and the ways in which their product portfolios will evolve in light of the stricter MDR standards.

Manufacturers can employ GAP analysis to determine areas that are in compliance with the MDR. They can also utilize it to determine the gap between the method and the MDR requirements they’re comparing to.

Simply put, it assists manufacturers of medical devices:

• Be aware of the requirements that have an impact on their company.
• Find out about their classification of medical devices in accordance with the MDR
• Find all gaps in non-compliance.
• Find out how you can meet the EU’s new MDR requirements,
• Create a customized analysis of their data according to the specific roles within the organization.

If manufacturers discover any weaknesses during the evaluation, that does not mean there is an issue to be concerned about. In the end, it is important to remember that the GAP analysis is a tool that identifies the potential to make improvements. The very act of a GAP analysis indicates a committed effort to continuous improvement while ensuring that all gaps are addressed.

When dealing with a gap, the manufacturer must follow an identifiable process which shows that the gap was found as a gap, and was acknowledged before being fixed. Manufacturers must also disclose the method they used to fix every gap.

If you require assistance in conducting UKCA  for Gap Analysis in UAE – Abu Dhabi, Dubai, Sharjah, Ajman, Umm Al Quwain, Ras Al Khaimah and Fujairah, or another aspect of medical device’s certification, contact our knowledgeable team. We’ll review your request and determine the best MDR compliance specialist for you.

Before you sell a product in the GB market, it is necessary to make sure that the product is equipped with all the Technical Documentation as well as an official Declaration of Conformity.

• Technical Documentation The information contained in the technical file must prove the product’s compliance with the relevant regulatory requirements. The specific information that needs to be included varies based on the specific laws applicable for the particular product. 
• The general rule is that the documentation should be accompanied by details of the way in which the product is developed and manufactured, as well as being compliant with regulatory requirements. 
• The documentation should also contain the contact details of the manufacturer as well as the addresses of storage facilities.

Additionally, you must preserve the technical record for a minimum of 10-years after your product has been put on the market and be ready to supply it to market surveillance or enforcement authorities on demand.

Ascent provides a variety of certification services in UAE, Oman, Saudi Arabia, Kuwait, Qatar, Lebanon, and Jordan, including the development of new products as well as gap analysis, pre-assessment, and full assessing for compliance. Ascent – a Notified Body to apply for CE marking as well as an approved Body to mark UKCA products, UKCA certification, as well as the owner of certification is one of the largest test and certificate capabilities anywhere in the world. This gives confidence to your products and assisting you to gain access to the global market.

Furthermore, with the help by our UKCA Certification authorized Representative service, you can feel secure knowing that your product has been evaluated by our experts in technical files. If you sell electronics equipment, industrial machinery as well as medical instruments, we’ll make sure that your products comply to current UK Regulations.

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.