Why You Need to Choose the Right UK Approved Body?
Legal background
Choosing the right Approved Body is essential for ensuring timely access to the UK market and maintaining regulatory compliance. With only a limited number of Approved Bodies designated by the MHRA, demand is increasing rapidly. Manufacturers must act promptly to secure their UKCA certification through an Approved Body and avoid market disruption.
Failure to secure an Approved Body in time may lead to:
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- Inability to obtain UKCA certification, blocking access to the UK market.
- Delays in product launch due to long waiting lists and backlogs.
- Regulatory non-compliance, potentially leading to enforcement actions or product recalls.
- Disrupted business continuity if CE marking is no longer accepted.
Our services
How to get Body Corporate Approval? – UKCA Certification Partner
We support manufacturers in finding the right Approved Body for their UKCA certification. Leveraging our extensive network and in-depth regulatory expertise, we contact multiple Approved Bodies, present your technical documentation, and evaluate their scope, timelines, and capacity. We also assist in comparing offers and managing communication with the bodies during the selection and negotiation phases. With Obelis handling the Approved Body Selection and Negotiation, you gain faster access to certification channels and reduce the risk of delays, ensuring your medical devices remain compliant and market ready.
As part of our comprehensive healthcare services portfolio, we support technical file preparation, post-market surveillance, and regulatory intelligence, ensuring your UKCA journey is seamless from start to finish.
