UKCA

The regulatory landscape for medical devices in the UK and Europe has undergone significant transformation since Brexit. The divergence between UKCA (UK Conformity Assessed) marking and the CE Marking system has introduced new compliance challenges and opportunities for manufacturers. These changes have especially impacted medical device manufacturing companies operating across borders. This comprehensive guide explores […]

UK Medical Device Classification Navigating the UK’s medical device regulatory landscape can be overwhelming, especially following the UK’s departure from the EU. In this article, we’re breaking down the UK Medical Device Regulations 2002 (UK MDR 2002)—from classification basics to conformity assessment—so that manufacturers, distributors, and healthcare professionals can better understand their compliance obligations. What

An Overview: With the regulatory shift following Brexit, foreign medical device and IVD (in vitro diagnostic) manufacturers looking to enter the UK market must appoint a UK Responsible Person (UKRP) as mandated by the UK MDR 2002 (amended in 2019). This role is crucial for ensuring compliance with the Medicines and Healthcare Products Regulatory Agency