DEKRA Designated as UK Approved Body for Devices
DEKRA Certification UK Ltd Press Statement
DEKRA Certification UK Ltd is excited to announce that our UK Approved Body #8505 has now expanded in scope to include medical device UKCA conformity assessment.
The MHRA has updated its website confirming our designation.
The entry point is a reduced scope and we have the intention of expanding to match the combined scope of our two EU medical notified bodies (NB#0124 and NB#0344) in the coming months.
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Principal Certification Manager, Mr Steve Ward said, “DEKRA has an established international medical device testing and certification portfolio and we have a reputation for excellence in this market sector, particularly for cutting edge technologies and high risk products. As the first UK Approved Body to receive designation since Brexit, we are looking forward to fully participating in shaping the regulations for medical devices within the UK and becoming the partner of choice for medical device manufacturers seeking UKCA accreditation services.“
"We welcome DEKRA’s certification journey, which will provide much needed capacity to the system. We are also delighted that DEKRA have joined the ABHI membership this month – it is important that in addition to the manufacturers that make up our vibrant HealthTech sector, our membership should also encompasses those stakeholders like DEKRA who have a vital role to play in supporting innovators.”
Phil Brown, Director, Regulatory & Compliance