UKCA vs CE: How new requirements changed medical device manufacturing

Ashmita Das, CEO of scientific talent platform Kolabtree, sits down with freelancers Nare Simonyan and Nida Ali to discuss how the UKCA marking has impacted medical device manufacturing in the UK.

The UK Conformity Assessed (UKCA) marking is the new legally required product marking for goods being placed on the market in Great Britain from January 2021, covering most products that previously required a CE mark. While similar to the EU’s CE marking requirements, the UKCA means many must relearn the necessary requirements for medical device manufacturing.

CE marking is a self-declaration where a company demonstrates conformity with EU health, safety, and environmental regulations and affirms that a product meets essential standards. Similarly, UKCA marking demonstrates conformity with UK regulations. For medical devices intended for Great Britain’s market, a UKCA is needed. Currently, Great Britain is allowing a transitional period until 2023 for businesses to switch to UKCA.

AD: Can you explain the process of getting a UKCA mark?

NA: “The first step is creating a Declaration of Conformity to prove your medical device meets all the quality and technical requirements needed to perform its tasks. Manufacturers need an ISO to declare all requirements are met, including a statement from the manufacturer. Then a technical document is needed explaining the design, material, manufacturing, and records of how the device meets the relevant quality checks. For medical devices with 25% similarity to those already on the market, a clinical performance document is required. This can be compiled of relevant literature discussing the device compared to others on the market.”

NS: “It’s also important to note that the UKCA mark itself is not evidence of compliance – the technical documentation/technical file is. A Declaration of Conformity is a legal claim that products comply with applicable directives and standards but is not evidence of compliance.”

AD: How has the regulatory change impacted medical technologies/devices specifically?

NA: “UKCA is a regulatory process for products to be placed in Great Britain. It originated because of Brexit and is similar to the EU CE marking process. CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product's compliance with relevant requirements. In the same way, UKCA marking proves compliance with UK legislation.

The UKCA marking has incorporated its requirements from the EU’s MDR and applies to all aspects of medical devices. The UKCA is mostly mapped on the CE format but there is a slight variation. Products that show compliance with MDR will meet the UKCA as well. Most of the differences between the two systems are administrative in nature and reflect the fact that the UKCA mark only applies in Great Britain. By adhering to the MDR, the UKCA addresses safety issues and helps mitigate safety and quality risks to ensure devices are clinically safe for use. The UKCA also requires goods undergo third-party evaluation.”

NS: “The UKCA is not the only new regulation to come into effect in recent years. New and updated medical device regulations from jurisdictions like the US, EU, and Australia are refocusing compliance requirements for the medical technology industry. The changes are intended to enhance product quality and safety. For example, the UKCA requires human trials to be approved by the Medicines and Healthcare products Regulatory Agency. They are also meant to give companies better insight into the entire product lifecycle via improved quality metrics and a more efficient inspection process by simplifying the process and focusing on key aspects inspired by the CE marking. These changes could require strategic organisational and process transformation to ensure compliance and avoid loss of revenue and market share.”

AD: What are the common issues/bottlenecks with the new requirements manufacturers face when getting a UKCA mark?

NA: “The UKCA in many ways is actually simpler to the CE mark. This is because CE marking requires a lot more documentation, making it more expensive with extra inspections and time consuming. The CE guidance document can also be difficult to understand as there is lots of material, over 100 pages, making it easier to make mistakes. However, as the UKCA is only applicable for medical devices on the British market, the additional marking means that manufacturers bringing medical devices to both the EU and British markets need to spend more time obtaining both markings instead of just one.”

NS: “While this is true, for both parties (the UK seeking CE certification in the EU and the EU seeking UKCA conformity in the UK) time is of the essence. Yet for many manufacturers, the lack of time afforded to fulfil their regulatory obligations remains a critical issue of contention. The new product safety marking rules will affect businesses supplying most products on the market in Great Britain. The decision to delay the switchover is likely to have a huge impact on supply chains and consumers and it is hoped will prevent product shortages.”

AD: How can freelancers make the process easier? What specific services can they offer?

NA: “Freelancers can only assist in structuring the technical document or clinical evaluation. All documentation and record keeping from the time raw materials arrive at the facility to when goods are ready to be shipped must be documented by the in-house team. However, the clinical evaluation is typically given to freelancers as this needs to be outsourced for third party verification. Freelancers can identify any risks and raise questions before its approval. It’s crucial for the document to include all issues, post-market follow up, and all regulations the device will fall under. Freelancers can also create an analysis gap of the current document to identify areas left to fill in by the in-house team.”

NS: “Using the Guidance for UKCA marking freelancers can offer insight into the main requirements for the company services. Keeping on top of your product conformity requirements will now become more complex and time-consuming than ever, with many businesses juggling a mixture of UKCA and CE marking obligations. Quality management software can be applied in multiple ways to simplify, streamline, and support your product conformity processes and ease your organisation’s compliance burden.”