The Role of UKCA Marking in Product Safety

Manufacturers and importers are responsible for assessing whether their products meet the requirements and affixing the UKCA mark where applicable, reflecting a commitment to quality and safety in the UK marketplace.

Importance

The UKCA marking is a manufacturing compliance requirement for businesses looking to sell products in the UK market post-Brexit. Below are some key reasons why obtaining a UKCA mark is important:

Market Access

Securing UKCA marking provides long-term access to the UK market, one of Europe’s largest economies. With UKCA certification, your business can confidently sell products in Great Britain, a key global market for various industries, including medical devices. The UKCA mark ensures that your products meet the regulatory requirements to reach consumers in this significant market.

Quality and Safety

Undergoing the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) conformity assessment process enhances your product’s safety and reliability, minimizing the risk of recalls, customer complaints, and legal issues.

By prioritizing UKCA marking and MHRA compliance, your business is committed to meeting the highest safety and quality standards. This focus on safety boosts consumer trust and contributes to fewer product defects, extended product lifecycles, and better overall performance through robust design controls and risk management.

Differences Between CE and UKCA Mark

Although the UKCA mark is similar to the CE marking, there are some crucial differences that businesses need to be aware of. These include:

Geographic Scope

CE marking is recognized across the European Union and certain non-EU countries, including Norway, Iceland, and Liechtenstein. In contrast, the UKCA mark is specific to Great Britain (England, Scotland, and Wales). Northern Ireland has a unique status, where the CE and UKNI marking are used in certain cases.

Standards

For medical devices, CE marking compliance is based on EU MDR/IVDR regulations and requires registration with the EU’s Competent Authorities for Medical Devices (CAMD) and the EUDAMED database.

UKCA marking, however, follows the UK’s Medical Device Regulations 2002, with registration through the MHRA. While these standards are largely similar for now, the UK may diverge from EU regulations over time as it develops its independent regulatory framework.

Notified Bodies

These two product marking standards differ in the bodies authorized for conformity assessments. In the EU region, these are carried out by EU-recognized notified bodies. Meanwhile, UKCA mark assessments must be completed by UK-based approved bodies, which may involve processes or requirements different from those of their EU counterparts.

Personnel

For non-UK manufacturers, a UK Responsible Person (UKRP) is required to complete the UKCA marking process. In the EU, an EU Authorised Representative (EAR) is necessary for non-EU businesses to comply with CE marking requirements.

What Products Need UKCA Marking?

Understanding what products need UKCA marking is essential for businesses that wish to continue selling in the UK market.

UKCA marking applies to a broad range of product categories, encompassing, but not limited to, the following:

• Toys
• Electrical equipment
• Machinery
• Personal protective equipment (PPE)
• Construction products
• Medical devices
• Low-voltage electrical equipment

Medical Devices

Medical devices are among the most heavily regulated products under the UKCA marking system. Manufacturers must go through a detailed conformity assessment process to ensure their products meet the UK’s strict safety and performance standards set by the MHRA. This includes submitting a Declaration of Conformity and maintaining a technical file with product details, clinical evaluations, and design records.

Exceptions

Certain products, such as military equipment or items covered by other international agreements, are exempt from UKCA marking. While these products may need to meet relevant safety regulations, they don’t require the UKCA mark. For example, custom-made medical devices under clinical investigation or used for exceptional circumstances may not need UKCA marking.

How to Get UKCA Certification

Businesses aiming for UKCA certification can ensure a smooth, hassle-free process by following these steps:

Step 1: Create a Regulatory Strategy

Develop a clear regulatory strategy that aligns with your business goals. Key questions to consider include:

• Is your product a medical device or accessory?
• What legislation and standards apply?
• What risk class does your product fall under?
• Should you focus on the UK or Europe first?
• Can you reuse existing documentation?
• What verification and validation are required?

Step 2: Establish a Quality Management System (QMS)

Create and implement a QMS that meets the relevant UKCA and MHRA requirements. This involves establishing procedures for design, production, testing, labeling, packaging, storage, and distribution. An efficient QMS helps with compliance by identifying risks early on and streamlining processes.

Step 3: Gather Technical Documentation

Collect all required technical documentation for your product. Depending on the risk class of your product, this may include clinical evaluations, test reports, conformity assessments, risk management files, and declarations of conformity.

Step 4: Seek Approval from Authorized Bodies

After collecting all the required documents and information, the next step is to work with a UK-approved body to complete your UKCA certification. These organizations handle conformity assessments and ensure your product complies with UK regulations.

Here are some of the approved bodies you can work with for your UKCA marking:

• British Standards Institution (BSI)
• DEKRA
• Société Générale de Surveillance (SGS)
• UL Solutions
• TUV Rheinland
• TUV SUD
• Intertek

Step 5: Perform Post-certification Responsibilities

After achieving UKCA certification, your responsibilities as a manufacturer don’t end. To maintain compliance, you must:

• Conduct regular product testing and quality assurance checks
• Keep your technical file updated with any product changes or modifications
• Respond promptly to product safety incidents or reports of noncompliance