Why Selecting the Right UK Approved Body Matters
Legal background
Selecting the right UK Approved Body is essential for obtaining UKCA certification and placing medical devices and IVDs on the Great Britain market. As only a limited number of organisations are designated by the MHRA, early selection helps avoid delays, supports regulatory compliance, and ensures a smoother route to market.
The risks of delaying Approved Body selection
What's at stake without the right Approved Body
Delayed UKCA certification
Without an Approved Body, manufacturers may be unable to obtain UKCA certification and access the Great Britain market.
Longer time to market
High demand and limited availability can lead to lengthy waiting lists and certification delays.
Regulatory non-compliance
Delays in conformity assessment may increase the risk of enforcement action, product recalls, or compliance issues.
Business disruption
Failure to secure an Approved Body in time can interrupt market access as CE marking transitions to UKCA requirements.
Our services
How Approved Body Selection Works
We help manufacturers identify the most suitable Approved Body for their UKCA certification needs. Drawing on our broad network and deep regulatory knowledge, we reach out to several Approved Bodies, share your technical documentation, and assess each one’s scope, timelines, and capacity. We also help you compare proposals and manage ongoing communication throughout the selection and negotiation stages. By letting Obelis UK lead the Approved Body Selection and Negotiation process, you gain quicker access to certification pathways and lower the risk of delay, keeping your medical devices compliant and ready for market.
As part of our broader healthcare compliance offering, we also assist with technical documentation review, post-market surveillance, and regulatory intelligence, so your UKCA journey runs smoothly from beginning to end.
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Step 1
Assess Your Certification Needs
We evaluate your medical device, classification, and UKCA certification requirements to identify the most suitable Approved Bodies.
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Step 2
Match You with the Right Approved Body
Using our extensive network and industry contacts, we identify and approach the UK Approved Bodies best suited to your product, timelines, and regulatory needs.
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Step 3
Coordinate the Certification Process
We manage communication with the selected Approved Body, support technical documentation submissions, and guide you through the certification process to help achieve UKCA marking efficiently.
Related Services
Compliance for Medical Devices in the United Kingdom
Frequently Asked Questions
An Approved Body (AB) is a conformity assessment organisation designated by the Medicines and Healthcare products Regulatory Agency (MHRA) to assess whether medical devices and IVDs comply with UK MDR requirements. For most devices, an Approved Body must complete a conformity assessment before the UKCA mark can be applied and the product can be placed on the Great Britain market.
Most medical devices and certain IVDs require assessment by a UK Approved Body before obtaining UKCA certification. Exceptions include most Class I medical devices that are neither sterile nor measuring devices, and standard IVDs that do not require involvement of an Approved Body under the applicable UK regulations.
Choosing the right Approved Body depends on factors such as your device classification, the body’s designated scope, certification timelines, technical expertise, and current capacity. Selecting the right Approved Body early can help reduce delays, support a smoother UKCA certification process, and accelerate access to the Great Britain market. At Obelis, we leverage our extensive network of UK Approved Bodies and established industry relationships to help manufacturers identify the most suitable partner, compare available options, and facilitate communication throughout the selection process.
Yes. Obelis helps manufacturers identify the most suitable UK Approved Body for their medical devices or IVDs, compares certification options, and manages communication throughout the selection process. We also support technical documentation review, regulatory strategy, and coordination with the Approved Body to help streamline your UKCA certification journey.